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Senior Scientist - Analytical Development

  • Job
    Full-time
    Mid & Senior Level
  • Science
  • Chicago

AI generated summary

  • You need a Bachelor's/Master's/PhD in lab sciences, 4+ years experience, cGMP knowledge, technical writing skills, proficiency in analytical techniques and software, strong problem-solving abilities, and the ability to work in a collaborative environment.
  • You will conduct complex analytical testing, document data, mentor team members, communicate project status, ensure compliance, and optimize laboratory operations for Thermo Fisher Scientific.

Requirements

  • Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
  • Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
  • OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
  • OR PhD
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Knowledge, Skills and Abilities:
  • Demonstrated knowledge of multiple applicable techniques such as: Compendial analysis, Coulometric Karl Fisher, UV-VIS, HPLC, icIEF and CE-SDS and other biopharmaceutical testing.
  • At least one year of cGMP experience in a regulated lab is required.
  • Proficient in Microsoft Excel and Word.
  • Proficient in Empower.
  • Proven ability to interpret data by performing trend analysis.
  • Understanding and knowledge of general chemistry and separation science.
  • Proven ability in technical writing skills.
  • Ability to independently optimize analytical methods.
  • Proven problem solving and troubleshooting abilities.
  • Effective written and oral communication skills.
  • Time management and project management skills.
  • Statistical knowledge and experience are preferred.
  • Ability to work in a collaborative work environment with a team.
  • Ability to be flexible and be able to re-prioritize in a short notice to meet business needs.
  • Working Environment:
  • Below is listed the working environment/requirements for this role:
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary and/or standing for typical working hours.
  • Able to lift and move objects up to 25 pounds
  • Able to work in non-traditional work environments.
  • Able to use and learn standard office equipment and technology with
  • proficiency.
  • May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

  • Performs a variety of complex sample preparation and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations for release and stability accurately and in timely and safe manner.
  • Independently performs method validations and method transfers. Designs and completes experiments with minimal supervision.
  • Documents experimental data appropriately and accurately in electronic laboratory notebook; assists in writing technical reports.
  • Works with multiple functional groups to meet business needs.
  • Plans and organizes work with periodic supervision.
  • Sets up and maintains laboratory equipment, optimizes laboratory operations for efficient use of time and resources.
  • Ensures QA findings are addressed appropriately.
  • Mentors and trains other team members and assists in instrument troubleshooting and analytical problems.
  • Communicates project status, data and technical issues to project lead and responds to leaders’ needs and questions.
  • Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
  • Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
  • Understands and adheres to corporate standards regarding code of conduct, safety, and cGMP compliance.

FAQs

What are the key responsibilities of a Senior Scientist in Analytical Development?

The key responsibilities include performing complex sample preparation and analytical testing of pharmaceutical and biopharmaceutical compounds, independently performing method validations and transfers, documenting experimental data accurately, collaborating with cross-functional teams, mentoring and training team members, and ensuring compliance with quality and regulatory standards.

What is the required education and experience for a Senior Scientist in Analytical Development?

A Bachelor's degree in lab sciences such as Chemistry, Biochemistry, or Biology is required. For a Senior Scientist, previous experience equivalent to 4+ years is necessary, or a Master's degree with 2+ years of experience, or a PhD. In some cases, a combination of education, training, and experience may be considered.

What skills and abilities are essential for a Senior Scientist in Analytical Development?

Essential skills include knowledge of analytical techniques such as HPLC, UV-VIS, and biopharmaceutical testing, proficiency in Microsoft Excel and Word, ability to interpret data and perform trend analysis, technical writing skills, problem-solving abilities, and effective communication skills. Time management, project management, and statistical knowledge are also preferred.

What is the working environment like for a Senior Scientist in Analytical Development?

The working environment may involve communicating with diverse groups, working upright or stationary for extended periods, lifting objects up to 25 pounds, working in non-traditional environments, using standard office equipment, and potential exposure to hazardous elements. The ability to perform under pressure, prioritize tasks, and handle multiple projects is essential.

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.