Genezen is a biotechnology company specialising in cell and gene therapy manufacturing. They focus on providing comprehensive services for the production of advanced therapies, including vector production and cell processing. Genezen’s approach combines expertise in cutting-edge technology with rigorous quality standards to support the development and delivery of innovative treatments. Their goal is to advance therapeutic solutions and facilitate the progress of gene and cell-based therapies through their state-of-the-art facilities and customised support.

Science & Healthcare

Genezen

Accelerating the Pace of Cell Therapy CMC and Clinical Development

You need a BS/MS in business or related field, APICS certification, 1-2 years GMP experience, ERP familiarity, and strong communication skills. Adaptability and problem-solving are essential.

You will assist with GMP material procurement, monitor inventory, coordinate with vendors, manage supplier documentation, update ERP data, and support cross-functional teams while learning best practices.

Logistics

Research & Development

Lexington

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Procurement Specialist I role is integral to the on-time delivery of compliant materials for Operations. This role supports the day-to-day purchasing of materials and management of vendors by working with internal stakeholders and managing external relationships. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures. JOB RESPONSIBILITIES: * Assist in the procurement of GMP materials in compliance with company policies and procedures. * Monitor inventory levels and support analysis of historical trends to help prevent stockouts. * Support the tracking and reporting of supplier freight and expedite costs. * Coordinate with vendors to gather quotes, confirm lead times, and process purchase orders. * Assist in managing supplier documentation, including Vendor Change Notifications and Corrective Action Requests, under the guidance of senior staff. * Maintain and update item master data in the ERP system as directed. * Support internal teams by gathering information and helping assess material needs. * Collaborate with cross-functional teams such as Manufacturing, Quality Assurance, Planning, and Warehouse to support procurement activities. * Learn and apply GMP and procurement best practices through daily activities and team training. KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired BS/MS degree in business or related field (e.g., Business Management, Supply Chain, or Finance) Essential APICS Certification Essential ON-THE-JOB EXPERIENCE 1-2 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment Essential Well versed in cGMP/ICH/FDA/EU regulations and guidelines Desired 1-2 years experience working with ERP systems Essential SKILLS / ABILITIES Excellent computer, verbal, and written communication skills Essential Ability to work independently with minimal supervision, as well as working effectively as part of a team Essential Ability to adapt quickly to change, such as but not limited to ideas, responsibilities, and strategies Essential Able to communicate in a professional way on diverse levels and channels Essential Takes the initiative to own and resolve issues Essential Analytical problem solving Essential Intrinsically Motivated Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment * Regularly sit for long periods of time Movement * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting * Frequently lift and/or move up to 10 pounds * Occasionally lift and/or move up to 25 pounds Vision * Frequently utilize close vision and the ability to adjust focus Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYThe Procurement Specialist I role is integral to the on-time delivery of compliant materials for Operations. This role supports the day-to-day purchasing of materials and management of vendors by working with internal stakeholders and managing external relationships. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures.JOB RESPONSIBILITIES: * Assist in the procurement of GMP materials in compliance with company policies and procedures. * Monitor inventory levels and support analysis of historical trends to help prevent stockouts. * Support the tracking and reporting of supplier freight and expedite costs. * Coordinate with vendors to gather quotes, confirm lead times, and process purchase orders. * Assist in managing supplier documentation, including Vendor Change Notifications and Corrective Action Requests, under the guidance of senior staff. * Maintain and update item master data in the ERP system as directed. * Support internal teams by gathering information and helping assess material needs. * Collaborate with cross-functional teams such as Manufacturing, Quality Assurance, Planning, and Warehouse to support procurement activities. * Learn and apply GMP and procurement best practices through daily activities and team training.      KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS/MS degree in business or related field (e.g., Business Management, Supply Chain, or Finance)EssentialAPICS CertificationEssentialON-THE-JOB EXPERIENCE1-2 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environmentEssentialWell versed in cGMP/ICH/FDA/EU regulations and guidelinesDesired1-2 years experience working with ERP systemsEssentialSKILLS / ABILITIESExcellent computer, verbal, and written communication skillsEssentialAbility to work independently with minimal supervision, as well as working effectively as part of a teamEssentialAbility to adapt quickly to change, such as but not limited to ideas, responsibilities, and strategiesEssentialAble to communicate in a professional way on diverse levels and channelsEssentialTakes the initiative to own and resolve issuesEssentialAnalytical problem solvingEssentialIntrinsically MotivatedEssentialPHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Work Environment * Regularly sit for long periods of time      Movement * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl      Lifting * Frequently lift and/or move up to 10 pounds * Occasionally lift and/or move up to 25 pounds      Vision * Frequently utilize close vision and the ability to adjust focus      Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail      GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance      ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.      Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Procurement Specialist I - Genezen

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.&lt;br&gt;&lt;br&gt;&lt;strong&gt;WORKING AT GENEZEN&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.&lt;br&gt;&lt;br&gt;&lt;strong&gt;JOB SUMMARY&lt;br&gt;&lt;br&gt;&lt;/strong&gt;The Procurement Specialist I role is integral to the on-time delivery of compliant materials for Operations. This role supports the day-to-day purchasing of materials and management of vendors by working with internal stakeholders and managing external relationships. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures.&lt;br&gt;&lt;br&gt;&lt;strong&gt;JOB RESPONSIBILITIES:&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Assist in the procurement of GMP materials in compliance with company policies and procedures.&lt;/li&gt;&lt;li&gt;Monitor inventory levels and support analysis of historical trends to help prevent stockouts.&lt;/li&gt;&lt;li&gt;Support the tracking and reporting of supplier freight and expedite costs.&lt;/li&gt;&lt;li&gt;Coordinate with vendors to gather quotes, confirm lead times, and process purchase orders.&lt;/li&gt;&lt;li&gt;Assist in managing supplier documentation, including Vendor Change Notifications and Corrective Action Requests, under the guidance of senior staff.&lt;/li&gt;&lt;li&gt;Maintain and update item master data in the ERP system as directed.&lt;/li&gt;&lt;li&gt;Support internal teams by gathering information and helping assess material needs.&lt;/li&gt;&lt;li&gt;Collaborate with cross-functional teams such as Manufacturing, Quality Assurance, Planning, and Warehouse to support procurement activities.&lt;/li&gt;&lt;li&gt;Learn and apply GMP and procurement best practices through daily activities and team training.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;KNOWLEDGE, SKILLS AND EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;EDUCATION / CERTIFICATIONS / LICENSES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;Essential/Desired&lt;br&gt;&lt;br&gt;&lt;/strong&gt;BS/MS degree in business or related field (e.g., Business Management, Supply Chain, or Finance)&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;APICS Certification&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;ON-THE-JOB EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;/strong&gt;1-2 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Well versed in cGMP/ICH/FDA/EU regulations and guidelines&lt;br&gt;&lt;br&gt;Desired&lt;br&gt;&lt;br&gt;1-2 years experience working with ERP systems&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;SKILLS / ABILITIES&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Excellent computer, verbal, and written communication skills&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Ability to work independently with minimal supervision, as well as working effectively as part of a team&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Ability to adapt quickly to change, such as but not limited to ideas, responsibilities, and strategies&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Able to communicate in a professional way on diverse levels and channels&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Takes the initiative to own and resolve issues&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Analytical problem solving&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Intrinsically Motivated&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;PHYSICAL DEMANDS &lt;br&gt;&lt;br&gt;&lt;/strong&gt;While performing the duties of this job, the employee is required to meet the following physical demands:&lt;br&gt;&lt;br&gt;Work Environment&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Regularly sit for long periods of time&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Movement&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms&lt;/li&gt;&lt;li&gt;Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Lifting&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently lift and/or move up to 10 pounds&lt;/li&gt;&lt;li&gt;Occasionally lift and/or move up to 25 pounds&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Vision&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently utilize close vision and the ability to adjust focus &lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Communication&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to communicate by talking, hearing, using telephone and e-mail&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;GENEZEN'S CURES VALUE-BASED COMPETENCIES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;C&lt;/strong&gt;ommitted to Science&lt;br&gt;&lt;br&gt;We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.&lt;br&gt;&lt;br&gt;&lt;strong&gt;U&lt;/strong&gt;rgency in action for the patients&lt;br&gt;&lt;br&gt;We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.&lt;br&gt;&lt;br&gt;&lt;strong&gt;R&lt;/strong&gt;esilience &amp;amp; Grit in operations&lt;br&gt;&lt;br&gt;We are committed to overcoming challenges, learning from failures, and persistently striving for success.&lt;br&gt;&lt;br&gt;&lt;strong&gt;E&lt;/strong&gt;xecute with Excellence &amp;amp; Integrity&lt;br&gt;&lt;br&gt;We are dedicated to delivering quality results and upholding ethical principals.&lt;br&gt;&lt;br&gt;&lt;strong&gt;S&lt;/strong&gt;olutions driven for our partners&lt;br&gt;&lt;br&gt;We are committed to being a proactive, collaborative, creative and open-minded partner.&lt;br&gt;&lt;br&gt;&lt;strong&gt;GENEZEN'S BENEFITS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Paid vacation days, amount based on tenure&lt;/li&gt;&lt;li&gt;Paid sick time&lt;/li&gt;&lt;li&gt;10 observed holidays + 2 floating holiday + 1 volunteer day&lt;/li&gt;&lt;li&gt;401(k) plan with company match up to 6% of salary, vested immediately&lt;/li&gt;&lt;li&gt;Share Appreciation Rights&lt;/li&gt;&lt;li&gt;Choice of several healthcare plans&lt;/li&gt;&lt;li&gt;FSA and HSA programs&lt;/li&gt;&lt;li&gt;Dental &amp;amp; vision care&lt;/li&gt;&lt;li&gt;Employer-paid basic term life/personal accident insurance&lt;/li&gt;&lt;li&gt;Voluntary disability, universal life/personal accident insurance&lt;/li&gt;&lt;li&gt;Accidental Death &amp;amp; Dismemberment (AD&amp;amp;D) Insurance&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;ADDITIONAL DETAILS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.&lt;/li&gt;&lt;li&gt;This position requires a criminal background check.&lt;/li&gt;&lt;li&gt;Genezen is an Equal Opportunity Employer.&lt;/li&gt;&lt;li&gt;Genezen participates in EVerify.&lt;/li&gt;&lt;li&gt;Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.&lt;br&gt;&lt;br&gt;Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.&lt;br&gt;&lt;br&gt;Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Procurement Specialist I

You should have 5-7 years in lab safety/biosafety, knowledge of OSHA/EPA, data visualization skills, and a related degree. Experience in biopharma, ESG reporting, and Lean certification is preferred.

You will manage HSE programs, assess risks, conduct training, lead incident response, oversee compliance, manage budgets, and drive continuous improvement initiatives.

Engineering

Healthcare

Indianapolis

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The HSE Lead is responsible for managing HSE programs, ensuring compliance and driving continuous improvement in a cell and gene therapy biomanufacturing environment. The HSE Lead plays a key role in the operations of Genezen by promoting a safety and continuous improvement culture across all levels of the organization. ESSENTIAL JOB FUNCTIONS * Develop and manage HSE programs including but not limited to emergency preparation (CPR/first aid, spill response), chemical hygiene, biosafety plan, contractor safety, bloodborne pathogens, industrial hygiene, hazardous waste management and wastewater treatment * Evaluate facility HSE conditions, assess risks, and develop appropriate corrective-action plans and budgets to make improvements * Facilitate HSE related risk assessments as they pertain to new equipment or process introduction, ensuring the proper hazard assessment and risk mitigation * Maintain HSE leading indicator reporting through proactive engagement and analysis. Maintain incident and injury record reporting system * Manage vendor programs including hazardous waste & biological waste management and pest control * Coordinate and deploy formal and informal HSE training. Includes both external training vendors and/or develop internal training. * Serve as site Emergency Coordinator for incidents, personnel injury or fire response. Implement and drive meaningful corrective actions to prevent future occurrences. * Manage municipal, state, and federal permitting requirements for a biological manufacturing facility * Represent Genezen during applicable regulatory or client audits and inspections * Manage annual HSE budget * Supports site continuous improvement initiatives through use of continuous improvement tools, templates, dashboards and internal communications * Supports visual daily management (Tier meeting), including development of leading indicators * Leads proactive-learning activities such as After Action Reviews, cross-functional workshops, and kaizen events SPECIAL JOB REQUIREMENTS * Experience with Lab Safety and/or Biosafety * Working knowledge of government regulations and industry standards, including OSHA, EPA, DOT, RCRA, NFPPA * Proficiency in MS Office including Word, Excel, and PowerPoint * Skills in data visualization (Power BI, Power Query, PowerApps) * Experience with quality system compliance * Interest in human factors & system safety (aka human & organizational performance) * Ability to travel domestically (5%) KNOWLEDGE, SKILLS AND EXPERIENCE * Bachelor’s Degree in Occupational Health/Safety, Engineering or related field * 5-7 years related work experience * Experience working in biopharmaceutical manufacturing facility * Experience working in a lab safety environment * Thorough knowledge of federal and local EHS regulations including OSHA and EPA * Lab Safety & Biosafety experience, such as professional course work or work towards a Registered Biosafety Professional Certificate * Lean/Continuous Improvement certification or professional level coursework (Yellow Belt) * Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential * ESG reporting experience PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Occasionally required to work in a GMP clean room environment with personal protective equipment/aseptic gowning * Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities * Spending time on the floor during activity execution is required * While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. * In the performance of the duties of this job the employee is required to communicate using telephone and e-mail. GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYThe HSE Lead is responsible for managing HSE programs, ensuring compliance and driving continuous improvement in a cell and gene therapy biomanufacturing environment. The HSE Lead plays a key role in the operations of Genezen by promoting a safety and continuous improvement culture across all levels of the organization.ESSENTIAL JOB FUNCTIONS * Develop and manage HSE programs including but not limited to emergency preparation (CPR/first aid, spill response), chemical hygiene, biosafety plan, contractor safety, bloodborne pathogens, industrial hygiene, hazardous waste management and wastewater treatment * Evaluate facility HSE conditions, assess risks, and develop appropriate corrective-action plans and budgets to make improvements * Facilitate HSE related risk assessments as they pertain to new equipment or process introduction, ensuring the proper hazard assessment and risk mitigation * Maintain HSE leading indicator reporting through proactive engagement and analysis. Maintain incident and injury record reporting system * Manage vendor programs including hazardous waste & biological waste management and pest control * Coordinate and deploy formal and informal HSE training. Includes both external training vendors and/or develop internal training. * Serve as site Emergency Coordinator for incidents, personnel injury or fire response. Implement and drive meaningful corrective actions to prevent future occurrences. * Manage municipal, state, and federal permitting requirements for a biological manufacturing facility * Represent Genezen during applicable regulatory or client audits and inspections * Manage annual HSE budget * Supports site continuous improvement initiatives through use of continuous improvement tools, templates, dashboards and internal communications * Supports visual daily management (Tier meeting), including development of leading indicators * Leads proactive-learning activities such as After Action Reviews, cross-functional workshops, and kaizen events      SPECIAL JOB REQUIREMENTS * Experience with Lab Safety and/or Biosafety * Working knowledge of government regulations and industry standards, including OSHA, EPA, DOT, RCRA, NFPPA * Proficiency in MS Office including Word, Excel, and PowerPoint * Skills in data visualization (Power BI, Power Query, PowerApps) * Experience with quality system compliance * Interest in human factors & system safety (aka human & organizational performance) * Ability to travel domestically (5%)      KNOWLEDGE, SKILLS AND EXPERIENCE * Bachelor’s Degree in Occupational Health/Safety, Engineering or related field * 5-7 years related work experience * Experience working in biopharmaceutical manufacturing facility * Experience working in a lab safety environment * Thorough knowledge of federal and local EHS regulations including OSHA and EPA * Lab Safety & Biosafety experience, such as professional course work or work towards a Registered Biosafety Professional Certificate * Lean/Continuous Improvement certification or professional level coursework (Yellow Belt) * Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential * ESG reporting experience      PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Occasionally required to work in a GMP clean room environment with personal protective equipment/aseptic gowning * Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities * Spending time on the floor during activity execution is required * While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. * In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.      GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance      ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.      Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Health, Safety, and Environmental (HSE) Lead - Genezen

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.&lt;br&gt;&lt;br&gt;&lt;strong&gt;WORKING AT GENEZEN&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.&lt;br&gt;&lt;br&gt;&lt;strong&gt;JOB SUMMARY&lt;br&gt;&lt;br&gt;&lt;/strong&gt;The HSE Lead is responsible for managing HSE programs, ensuring compliance and driving continuous improvement in a cell and gene therapy biomanufacturing environment. The HSE Lead plays a key role in the operations of Genezen by promoting a safety and continuous improvement culture across all levels of the organization.&lt;br&gt;&lt;br&gt;&lt;strong&gt;ESSENTIAL JOB FUNCTIONS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Develop and manage HSE programs including but not limited to emergency preparation (CPR/first aid, spill response), chemical hygiene, biosafety plan, contractor safety, bloodborne pathogens, industrial hygiene, hazardous waste management and wastewater treatment&lt;/li&gt;&lt;li&gt;Evaluate facility HSE conditions, assess risks, and develop appropriate corrective-action plans and budgets to make improvements&lt;/li&gt;&lt;li&gt;Facilitate HSE related risk assessments as they pertain to new equipment or process introduction, ensuring the proper hazard assessment and risk mitigation&lt;/li&gt;&lt;li&gt;Maintain HSE leading indicator reporting through proactive engagement and analysis. Maintain incident and injury record reporting system&lt;/li&gt;&lt;li&gt;Manage vendor programs including hazardous waste &amp;amp; biological waste management and pest control&lt;/li&gt;&lt;li&gt;Coordinate and deploy formal and informal HSE training. Includes both external training vendors and/or develop internal training.&lt;/li&gt;&lt;li&gt;Serve as site Emergency Coordinator for incidents, personnel injury or fire response. Implement and drive meaningful corrective actions to prevent future occurrences.&lt;/li&gt;&lt;li&gt;Manage municipal, state, and federal permitting requirements for a biological manufacturing facility&lt;/li&gt;&lt;li&gt;Represent Genezen during applicable regulatory or client audits and inspections&lt;/li&gt;&lt;li&gt;Manage annual HSE budget&lt;/li&gt;&lt;li&gt;Supports site continuous improvement initiatives through use of continuous improvement tools, templates, dashboards and internal communications&lt;/li&gt;&lt;li&gt;Supports visual daily management (Tier meeting), including development of leading indicators&lt;/li&gt;&lt;li&gt;Leads proactive-learning activities such as After Action Reviews, cross-functional workshops, and kaizen events&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;SPECIAL JOB REQUIREMENTS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Experience with Lab Safety and/or Biosafety&lt;/li&gt;&lt;li&gt;Working knowledge of government regulations and industry standards, including OSHA, EPA, DOT, RCRA, NFPPA&lt;/li&gt;&lt;li&gt;Proficiency in MS Office including Word, Excel, and PowerPoint&lt;/li&gt;&lt;li&gt;Skills in data visualization (Power BI, Power Query, PowerApps)&lt;/li&gt;&lt;li&gt;Experience with quality system compliance&lt;/li&gt;&lt;li&gt;Interest in human factors &amp;amp; system safety (aka human &amp;amp; organizational performance)&lt;/li&gt;&lt;li&gt;Ability to travel domestically (5%)&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;KNOWLEDGE, SKILLS AND EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Bachelor’s Degree in Occupational Health/Safety, Engineering or related field&lt;/li&gt;&lt;li&gt;5-7 years related work experience&lt;/li&gt;&lt;li&gt;Experience working in biopharmaceutical manufacturing facility&lt;/li&gt;&lt;li&gt;Experience working in a lab safety environment&lt;/li&gt;&lt;li&gt;Thorough knowledge of federal and local EHS regulations including OSHA and EPA&lt;/li&gt;&lt;li&gt;Lab Safety &amp;amp; Biosafety experience, such as professional course work or work towards a Registered Biosafety Professional Certificate&lt;/li&gt;&lt;li&gt;Lean/Continuous Improvement certification or professional level coursework (Yellow Belt)&lt;/li&gt;&lt;li&gt;Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential&lt;/li&gt;&lt;li&gt;ESG reporting experience&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;PHYSICAL DEMANDS &lt;br&gt;&lt;br&gt;&lt;/strong&gt;The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Occasionally required to work in a GMP clean room environment with personal protective equipment/aseptic gowning&lt;/li&gt;&lt;li&gt;Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities&lt;/li&gt;&lt;li&gt;Spending time on the floor during activity execution is required&lt;/li&gt;&lt;li&gt;While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. &lt;/li&gt;&lt;li&gt;In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;GENEZEN'S CURES VALUE-BASED COMPETENCIES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;C&lt;/strong&gt;ommitted to Science&lt;br&gt;&lt;br&gt;We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.&lt;br&gt;&lt;br&gt;&lt;strong&gt;U&lt;/strong&gt;rgency in action for the patients&lt;br&gt;&lt;br&gt;We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.&lt;br&gt;&lt;br&gt;&lt;strong&gt;R&lt;/strong&gt;esilience &amp;amp; Grit in operations&lt;br&gt;&lt;br&gt;We are committed to overcoming challenges, learning from failures, and persistently striving for success.&lt;br&gt;&lt;br&gt;&lt;strong&gt;E&lt;/strong&gt;xecute with Excellence &amp;amp; Integrity&lt;br&gt;&lt;br&gt;We are dedicated to delivering quality results and upholding ethical principals.&lt;br&gt;&lt;br&gt;&lt;strong&gt;S&lt;/strong&gt;olutions driven for our partners&lt;br&gt;&lt;br&gt;We are committed to being a proactive, collaborative, creative and open-minded partner.&lt;br&gt;&lt;br&gt;&lt;strong&gt;GENEZEN'S BENEFITS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Paid vacation days, amount based on tenure&lt;/li&gt;&lt;li&gt;Paid sick time&lt;/li&gt;&lt;li&gt;10 observed holidays + 2 floating holiday + 1 volunteer day&lt;/li&gt;&lt;li&gt;401(k) plan with company match up to 6% of salary, vested immediately&lt;/li&gt;&lt;li&gt;Share Appreciation Rights&lt;/li&gt;&lt;li&gt;Choice of several healthcare plans&lt;/li&gt;&lt;li&gt;FSA and HSA programs&lt;/li&gt;&lt;li&gt;Dental &amp;amp; vision care&lt;/li&gt;&lt;li&gt;Employer-paid basic term life/personal accident insurance&lt;/li&gt;&lt;li&gt;Voluntary disability, universal life/personal accident insurance&lt;/li&gt;&lt;li&gt;Accidental Death &amp;amp; Dismemberment (AD&amp;amp;D) Insurance&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;ADDITIONAL DETAILS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.&lt;/li&gt;&lt;li&gt;This position requires a criminal background check.&lt;/li&gt;&lt;li&gt;Genezen is an Equal Opportunity Employer.&lt;/li&gt;&lt;li&gt;Genezen participates in EVerify.&lt;/li&gt;&lt;li&gt;Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.&lt;br&gt;&lt;br&gt;Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.&lt;br&gt;&lt;br&gt;Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Health, Safety, and Environmental (HSE) Lead

You need a Bachelor's in Life Sciences/Engineering, 3 years GMP experience, 1 year in supervision, strong interpersonal skills, knowledge of aseptic processing, and drug substance experience.

You will lead and develop manufacturing teams, oversee production activities, ensure compliance with quality and safety standards, and drive process improvements for efficient operations.

Back to jobs Manufacturing Supervisor Indianapolis, IN The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality product; and continuously improve manufacturing processes. ESSENTIAL JOB FUNCTIONS * Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts * Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews * Oversee and execute Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review * Complete on-time delivery of product to clients, including review of Manufacturing records and investigations * Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements * Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS * Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety * Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc. * Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department SPECIAL WORK REQUIREMENTS * Adaptability required as work schedule may change based on business needs * Criminal background check required * Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Bachelor’s Degree in Life Sciences/Engineering Desired In-depth knowledge of aseptic processing Essential ON-THE-JOB EXPERIENCE 3 years of related work experience in a GMP environment Essential 1 year of supervisory experience Essential Drug Substance experience with cell culture and upstream/downstream processing Strongly Desired Experience using single use systems Desired SKILLS / ABILITIES Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs Essential Ability to manage multiple priorities Work Environment: * Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning * Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities * Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock * Occasionally exposed to extremely loud noise levels * Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required Movement: * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting * Frequently lift and/or move up to 10 pounds * Rarely lift and/or move up to 25 pounds Vision * Frequently utilize close vision and the ability to adjust focus Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Back to jobsManufacturing SupervisorIndianapolis, INThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYPromote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality product; and continuously improve manufacturing processes.ESSENTIAL JOB FUNCTIONS * Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts * Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews * Oversee and execute Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review * Complete on-time delivery of product to clients, including review of Manufacturing records and investigations * Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements * Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS * Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety * Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc. * Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department      SPECIAL WORK REQUIREMENTS * Adaptability required as work schedule may change based on business needs * Criminal background check required * Other duties as assigned      KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBachelor’s Degree in Life Sciences/EngineeringDesiredIn-depth knowledge of aseptic processingEssentialON-THE-JOB EXPERIENCE3 years of related work experience in a GMP environmentEssential1 year of supervisory experienceEssentialDrug Substance experience with cell culture and upstream/downstream processingStrongly DesiredExperience using single use systemsDesiredSKILLS / ABILITIESDemonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needsEssentialAbility to manage multiple prioritiesWork Environment: * Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning * Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities * Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock * Occasionally exposed to extremely loud noise levels * Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required      Movement: * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl      Lifting * Frequently lift and/or move up to 10 pounds * Rarely lift and/or move up to 25 pounds      Vision * Frequently utilize close vision and the ability to adjust focus      Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail      GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance      ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.      Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Manufacturing Supervisor - Genezen

Back to jobs&lt;br&gt;&lt;br&gt;Manufacturing Supervisor&lt;br&gt;&lt;br&gt;Indianapolis, IN&lt;br&gt;&lt;br&gt;The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.&lt;br&gt;&lt;br&gt;&lt;strong&gt;WORKING AT GENEZEN&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;JOB SUMMARY&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality product; and continuously improve manufacturing processes.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;ESSENTIAL JOB FUNCTIONS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts&lt;/li&gt;&lt;li&gt;Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews&lt;/li&gt;&lt;li&gt;Oversee and execute Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review&lt;/li&gt;&lt;li&gt;Complete on-time delivery of product to clients, including review of Manufacturing records and investigations&lt;/li&gt;&lt;li&gt;Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements&lt;/li&gt;&lt;li&gt;Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS&lt;/li&gt;&lt;li&gt;Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety&lt;/li&gt;&lt;li&gt;Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc.&lt;/li&gt;&lt;li&gt;Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;SPECIAL WORK REQUIREMENTS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Adaptability required as work schedule may change based on business needs&lt;/li&gt;&lt;li&gt;Criminal background check required&lt;/li&gt;&lt;li&gt;Other duties as assigned &lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;KNOWLEDGE, SKILLS AND EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;strong&gt;EDUCATION / CERTIFICATIONS / LICENSES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;&lt;strong&gt;Essential/Desired&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;Bachelor’s Degree in Life Sciences/Engineering&lt;br&gt;&lt;br&gt;Desired&lt;br&gt;&lt;br&gt;In-depth knowledge of aseptic processing&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;ON-THE-JOB EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;/strong&gt;3 years of related work experience in a GMP environment&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;1 year of supervisory experience&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Drug Substance experience with cell culture and upstream/downstream processing&lt;br&gt;&lt;br&gt;Strongly Desired&lt;br&gt;&lt;br&gt;Experience using single use systems&lt;br&gt;&lt;br&gt;Desired&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;SKILLS / ABILITIES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Ability to manage multiple priorities&lt;br&gt;&lt;br&gt;&lt;strong&gt;Work Environment:&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning&lt;/li&gt;&lt;li&gt;Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities&lt;/li&gt;&lt;li&gt;Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock&lt;/li&gt;&lt;li&gt;Occasionally exposed to extremely loud noise levels&lt;/li&gt;&lt;li&gt;Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;Movement:&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms&lt;/li&gt;&lt;li&gt;Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Lifting&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently lift and/or move up to 10 pounds&lt;/li&gt;&lt;li&gt;Rarely lift and/or move up to 25 pounds&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Vision&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently utilize close vision and the ability to adjust focus&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Communication&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to communicate by talking, hearing, using telephone and e-mail&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;GENEZEN'S CURES VALUE-BASED COMPETENCIES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;C&lt;/strong&gt;ommitted to Science&lt;br&gt;&lt;br&gt;We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.&lt;br&gt;&lt;br&gt;&lt;strong&gt;U&lt;/strong&gt;rgency in action for the patients&lt;br&gt;&lt;br&gt;We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.&lt;br&gt;&lt;br&gt;&lt;strong&gt;R&lt;/strong&gt;esilience &amp;amp; Grit in operations&lt;br&gt;&lt;br&gt;We are committed to overcoming challenges, learning from failures, and persistently striving for success.&lt;br&gt;&lt;br&gt;&lt;strong&gt;E&lt;/strong&gt;xecute with Excellence &amp;amp; Integrity&lt;br&gt;&lt;br&gt;We are dedicated to delivering quality results and upholding ethical principals.&lt;br&gt;&lt;br&gt;&lt;strong&gt;S&lt;/strong&gt;olutions driven for our partners&lt;br&gt;&lt;br&gt;We are committed to being a proactive, collaborative, creative and open-minded partner.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;GENEZEN'S BENEFITS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Paid vacation days, amount based on tenure&lt;/li&gt;&lt;li&gt;Paid sick time&lt;/li&gt;&lt;li&gt;10 observed holidays + 2 floating holiday + 1 volunteer day&lt;/li&gt;&lt;li&gt;401(k) plan with company match up to 6% of salary, vested immediately&lt;/li&gt;&lt;li&gt;Share Appreciation Rights&lt;/li&gt;&lt;li&gt;Choice of several healthcare plans&lt;/li&gt;&lt;li&gt;FSA and HSA programs&lt;/li&gt;&lt;li&gt;Dental &amp;amp; vision care&lt;/li&gt;&lt;li&gt;Employer-paid basic term life/personal accident insurance&lt;/li&gt;&lt;li&gt;Voluntary disability, universal life/personal accident insurance&lt;/li&gt;&lt;li&gt;Accidental Death &amp;amp; Dismemberment (AD&amp;amp;D) Insurance&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;ADDITIONAL DETAILS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.&lt;/li&gt;&lt;li&gt;This position requires a criminal background check.&lt;/li&gt;&lt;li&gt;Genezen is an Equal Opportunity Employer.&lt;/li&gt;&lt;li&gt;Genezen participates in EVerify.&lt;/li&gt;&lt;li&gt;Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.&lt;br&gt;&lt;br&gt;Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.&lt;br&gt;&lt;br&gt;Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Manufacturing Supervisor

You need a relevant Bachelor’s degree, 2-5 years in biopharma, lean manufacturing experience, proficiency in MS Office and data visualization, strong communication skills, and project management abilities.

You will analyze workflows, lead workshops, train staff on improvement practices, manage project frameworks, and support daily visual management for continuous improvement initiatives.

Back to jobs New Continuous Improvement Specialist I/II/III Lexington, MA The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Continuous Improvement Specialist is responsible for using engineering skills to support continuous improvement in daily operations, assisting in implementing continuous improvement ideas, and deploying continuous improvement principles across the organization. ESSENTIAL JOB FUNCTIONS * Defines complex internal/external problems by collecting data and information to understand how normal work-is-done * Interacts with cross-functional stakeholders to understand work-flow impediments and other wastes throughout the business. Selects appropriate lean tools to improve them. Ensure effective sustainment of results to close gaps to targets. * Lead cross-functional workshops, kaizen events * Maintains continuous improvement tools, templates, dashboards and internal communications * Develops and deploys formal, informal, and on-the-floor training on continuous improvement principles and improvement practices * rovide on-the-floor training of manufacturing and lab staff on human factors & system safety (aka human & organizational performance) * Supports visual daily management (Tier meeting), including development of leading indicators * Manage site project funnels and frameworks, including designing dashboards, templates, tools, * Leads proactive-learning activities such as After Action Reviews SPECIAL JOB REQUIREMENTS * Adaptability required as work schedule may change based on business needs. * Criminal background check required. * Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE Bachelor's Degree in a relevant science or engineering discipline (Industrial Engineering, Mechanical Engineering, Chemical Engineering, Biomedical engineering) Essential 2-5 years of biopharma manufacturing experience Essential Experience with lean manufacturing methodologies (A3, process map, kaizen practices) Essential Proficiency in MS Office including Word, Excel, and PowerPoint Essential Skills in data visualization (Power BI, Power Query, PowerApps) Essential Experience with quality system compliance Essential Interest in human factors & system safety (aka human & organizational performance) Essential Ability to travel domestically (5-10%) Essential Excellent Communication And Presentation Skills Essential Skilled in humble inquiry and creating a psychologically safe work environment Essential Strong leadership, collaboration, and cross-functional team building skills Essential Ability to teach and train others Essential Skilled in managing a project schedule, progress, risks, and communications to stakeholders Essential Openness to change and flexible for shifting project priorities Essential Skilled in meeting facilitation and effectiveness Essential Understanding of manufacturing and supply chain systems, including production planning, scheduling, and material management Essential Curiosity and creative problem solving Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment * Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning * Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities * Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock * Occasionally exposed to loud noise levels * Spending time on the floor during activity execution is required Movement * Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting * Frequently lift and/or move up to 25 pounds * Occasionally lift and/or move up to 40 pounds Vision * Frequently utilize close vision and the ability to adjust focus Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Back to jobsNewContinuous Improvement Specialist I/II/IIILexington, MAThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYThe Continuous Improvement Specialist is responsible for using engineering skills to support continuous improvement in daily operations, assisting in implementing continuous improvement ideas, and deploying continuous improvement principles across the organization.ESSENTIAL JOB FUNCTIONS * Defines complex internal/external problems by collecting data and information to understand how normal work-is-done * Interacts with cross-functional stakeholders to understand work-flow impediments and other wastes throughout the business. Selects appropriate lean tools to improve them. Ensure effective sustainment of results to close gaps to targets. * Lead cross-functional workshops, kaizen events * Maintains continuous improvement tools, templates, dashboards and internal communications * Develops and deploys formal, informal, and on-the-floor training on continuous improvement principles and improvement practices * rovide on-the-floor training of manufacturing and lab staff on human factors & system safety (aka human & organizational performance) * Supports visual daily management (Tier meeting), including development of leading indicators * Manage site project funnels and frameworks, including designing dashboards, templates, tools, * Leads proactive-learning activities such as After Action Reviews      SPECIAL JOB REQUIREMENTS * Adaptability required as work schedule may change based on business needs. * Criminal background check required. * Other duties as assigned      KNOWLEDGE, SKILLS AND EXPERIENCEBachelor's Degree in a relevant science or engineering discipline (Industrial Engineering, Mechanical Engineering, Chemical Engineering, Biomedical engineering)Essential2-5 years of biopharma manufacturing experienceEssentialExperience with lean manufacturing methodologies (A3, process map, kaizen practices)EssentialProficiency in MS Office including Word, Excel, and PowerPointEssentialSkills in data visualization (Power BI, Power Query, PowerApps)EssentialExperience with quality system complianceEssentialInterest in human factors & system safety (aka human & organizational performance)EssentialAbility to travel domestically (5-10%)Essential Excellent Communication And Presentation Skills EssentialSkilled in humble inquiry and creating a psychologically safe work environmentEssentialStrong leadership, collaboration, and cross-functional team building skillsEssentialAbility to teach and train othersEssential Skilled in managing a project schedule, progress, risks, and communications to stakeholders Essential Openness to change and flexible for shifting project priorities Essential Skilled in meeting facilitation and effectiveness Essential Understanding of manufacturing and supply chain systems, including production planning, scheduling, and material management Essential Curiosity and creative problem solving EssentialPHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Work Environment * Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning * Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities * Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock * Occasionally exposed to loud noise levels * Spending time on the floor during activity execution is required      Movement * Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl      Lifting * Frequently lift and/or move up to 25 pounds * Occasionally lift and/or move up to 40 pounds      Vision * Frequently utilize close vision and the ability to adjust focus      Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail      GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary, vested immediately * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance      ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.      Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Continuous Improvement Specialist I/II/III - Genezen

Back to jobs&lt;br&gt;&lt;br&gt;New&lt;br&gt;&lt;br&gt;Continuous Improvement Specialist I/II/III&lt;br&gt;&lt;br&gt;Lexington, MA&lt;br&gt;&lt;br&gt;The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.&lt;br&gt;&lt;br&gt;&lt;strong&gt;WORKING AT GENEZEN&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;JOB SUMMARY&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;The Continuous Improvement Specialist is responsible for using engineering skills to support continuous improvement in daily operations, assisting in implementing continuous improvement ideas, and deploying continuous improvement principles across the organization.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;ESSENTIAL JOB FUNCTIONS &lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Defines complex internal/external problems by collecting data and information to understand how normal work-is-done &lt;/li&gt;&lt;li&gt;Interacts with cross-functional stakeholders to understand work-flow impediments and other wastes throughout the business. Selects appropriate lean tools to improve them. Ensure effective sustainment of results to close gaps to targets.&lt;/li&gt;&lt;li&gt;Lead cross-functional workshops, kaizen events&lt;/li&gt;&lt;li&gt;Maintains continuous improvement tools, templates, dashboards and internal communications&lt;/li&gt;&lt;li&gt;Develops and deploys formal, informal, and on-the-floor training on continuous improvement principles and improvement practices &lt;/li&gt;&lt;li&gt;rovide on-the-floor training of manufacturing and lab staff on human factors &amp;amp; system safety (aka human &amp;amp; organizational performance) &lt;/li&gt;&lt;li&gt;Supports visual daily management (Tier meeting), including development of leading indicators &lt;/li&gt;&lt;li&gt;Manage site project funnels and frameworks, including designing dashboards, templates, tools, &lt;/li&gt;&lt;li&gt;Leads proactive-learning activities such as After Action Reviews &lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;SPECIAL JOB REQUIREMENTS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Adaptability required as work schedule may change based on business needs.&lt;/li&gt;&lt;li&gt;Criminal background check required.&lt;/li&gt;&lt;li&gt;Other duties as assigned&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;KNOWLEDGE, SKILLS AND EXPERIENCE&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;Bachelor's Degree in a relevant science or engineering discipline (Industrial Engineering, Mechanical Engineering, Chemical Engineering, Biomedical engineering)&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;2-5 years of biopharma manufacturing experience&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Experience with lean manufacturing methodologies (A3, process map, kaizen practices)&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Proficiency in MS Office including Word, Excel, and PowerPoint&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Skills in data visualization (Power BI, Power Query, PowerApps)&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Experience with quality system compliance&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Interest in human factors &amp;amp; system safety (aka human &amp;amp; organizational performance)&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Ability to travel domestically (5-10%)&lt;br&gt;&lt;br&gt;Essential Excellent Communication And Presentation Skills Essential&lt;br&gt;&lt;br&gt;Skilled in humble inquiry and creating a psychologically safe work environment&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Strong leadership, collaboration, and cross-functional team building skills&lt;br&gt;&lt;br&gt;&lt;strong&gt;Essential&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Ability to teach and train others&lt;br&gt;&lt;br&gt;Essential Skilled in managing a project schedule, progress, risks, and communications to stakeholders Essential Openness to change and flexible for shifting project priorities Essential Skilled in meeting facilitation and effectiveness Essential Understanding of manufacturing and supply chain systems, including production planning, scheduling, and material management Essential Curiosity and creative problem solving Essential&lt;br&gt;&lt;br&gt;&lt;strong&gt;PHYSICAL DEMANDS &lt;br&gt;&lt;br&gt;&lt;/strong&gt;While performing the duties of this job, the employee is required to meet the following physical demands:&lt;br&gt;&lt;br&gt;Work Environment&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning&lt;/li&gt;&lt;li&gt;Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities&lt;/li&gt;&lt;li&gt;Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock&lt;/li&gt;&lt;li&gt;Occasionally exposed to loud noise levels&lt;/li&gt;&lt;li&gt;Spending time on the floor during activity execution is required&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Movement&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms&lt;/li&gt;&lt;li&gt;Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Lifting&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently lift and/or move up to 25 pounds&lt;/li&gt;&lt;li&gt;Occasionally lift and/or move up to 40 pounds&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Vision&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently utilize close vision and the ability to adjust focus&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Communication&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Frequently required to communicate by talking, hearing, using telephone and e-mail&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;GENEZEN'S CURES VALUE-BASED COMPETENCIES&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;strong&gt;C&lt;/strong&gt;ommitted to Science&lt;br&gt;&lt;br&gt;We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.&lt;br&gt;&lt;br&gt;&lt;strong&gt;U&lt;/strong&gt;rgency in action for the patients&lt;br&gt;&lt;br&gt;We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.&lt;br&gt;&lt;br&gt;&lt;strong&gt;R&lt;/strong&gt;esilience &amp;amp; Grit in operations&lt;br&gt;&lt;br&gt;We are committed to overcoming challenges, learning from failures, and persistently striving for success.&lt;br&gt;&lt;br&gt;&lt;strong&gt;E&lt;/strong&gt;xecute with Excellence &amp;amp; Integrity&lt;br&gt;&lt;br&gt;We are dedicated to delivering quality results and upholding ethical principals.&lt;br&gt;&lt;br&gt;&lt;strong&gt;S&lt;/strong&gt;olutions driven for our partners&lt;br&gt;&lt;br&gt;We are committed to being a proactive, collaborative, creative and open-minded partner.&lt;br&gt;&lt;br&gt;&lt;strong&gt;&lt;strong&gt;GENEZEN'S BENEFITS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Paid vacation days, amount based on tenure&lt;/li&gt;&lt;li&gt;Paid sick time&lt;/li&gt;&lt;li&gt;10 observed holidays + 2 floating holiday + 1 volunteer day&lt;/li&gt;&lt;li&gt;401(k) plan with company match up to 6% of salary, vested immediately&lt;/li&gt;&lt;li&gt;Share Appreciation Rights&lt;/li&gt;&lt;li&gt;Choice of several healthcare plans&lt;/li&gt;&lt;li&gt;FSA and HSA programs&lt;/li&gt;&lt;li&gt;Dental &amp;amp; vision care&lt;/li&gt;&lt;li&gt;Employer-paid basic term life/personal accident insurance&lt;/li&gt;&lt;li&gt;Voluntary disability, universal life/personal accident insurance&lt;/li&gt;&lt;li&gt;Accidental Death &amp;amp; Dismemberment (AD&amp;amp;D) Insurance&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;&lt;strong&gt;ADDITIONAL DETAILS&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt;Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.&lt;/li&gt;&lt;li&gt;This position requires a criminal background check.&lt;/li&gt;&lt;li&gt;Genezen is an Equal Opportunity Employer.&lt;/li&gt;&lt;li&gt;Genezen participates in EVerify.&lt;/li&gt;&lt;li&gt;Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.&lt;br&gt;&lt;br&gt;Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.&lt;br&gt;&lt;br&gt;Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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