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Manufacturing Supervisor

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Genezen

30d ago

  • Job
    Full-time
    Mid Level
  • Healthcare
  • Indianapolis
  • Quick Apply

AI generated summary

  • 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.

Requirements

  • Bachelor’s Degree in Life Sciences/Engineering
  • 3 years of related work experience in a GMP environment
  • 1 year of supervisory experience
  • Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs
  • Ability to manage multiple priorities
  • In-depth knowledge of aseptic processing
  • Drug Substance experience with cell culture and upstream/downstream processing
  • Experience using single use systems
  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required

Responsibilities

  • 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

FAQs

What is the primary role of the Manufacturing Supervisor at Genezen?

The primary role of the Manufacturing Supervisor is to promote a safe working environment, lead the manufacturing team, ensure on-time execution of batch activities, deliver quality products, and continuously improve manufacturing processes.

What are the essential qualifications required for this role?

Essential qualifications include a Bachelor’s Degree in Life Sciences or Engineering, three years of related work experience in a GMP environment, and one year of supervisory experience.

Is previous experience in drug substance processing preferred?

Yes, experience in drug substance processing with cell culture and upstream/downstream processing is strongly desired.

What safety measures are in place for this job role?

The Manufacturing Supervisor must ensure a safe working environment by complying with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department.

Are there any special work requirements for this position?

Yes, adaptability is required as the work schedule may change based on business needs, and a criminal background check is mandatory.

What types of benefits does Genezen offer?

Genezen offers paid vacation and sick time, observed holidays, a 401(k) plan with company match, healthcare plans, life insurance, and more.

What working environment should a Manufacturing Supervisor expect?

The Manufacturing Supervisor should expect to work in a BSL 2 environment, around large machinery and utilities typically seen in pharmaceutical facilities, with occasional exposure to loud noise levels and hazardous materials.

Does Genezen support employee development?

Yes, Genezen is dedicated to the training and development of its manufacturing team members, including performance management and coaching.

Are employees required to wear personal protective equipment?

Yes, employees will frequently be required to wear personal protective equipment and aseptic gowning while working in the manufacturing environment.

Does Genezen participate in E-Verify?

Yes, Genezen participates in E-Verify as part of their hiring process.

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Genezen

Accelerating the Pace of Cell Therapy CMC and Clinical Development

Science & Healthcare
Industry
51-200
Employees
2014
Founded Year

Mission & Purpose

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.