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Senior Scientist - Labs - QC Stability

  • Job
    Full-time
    Junior & Mid Level
  • Science
  • Boston

AI generated summary

  • You need a Bachelor's or Master's degree in lab sciences with 2+ years of experience. Must have knowledge of cGMP, GDP, GLP, FDA, EMA, ICH regulations, and data analysis skills.
  • You will manage routine operations of stability programs for cell and genetic therapies, ensuring compliance with SOPs, drafting/revising protocols, coordinating with testing labs, addressing quality events, updating GMP documents, data entry/review in LIMS, supporting regulatory submissions, presenting updates, and performing data trending/review.

Requirements

  • Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
  • Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
  • OR Masters degree
  • 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:
  • Past experience with Quality Control, preferably with focus on stability
  • Good understanding of cGMP, GDP and GLP regulations and guidelines
  • Knowledge of clinical and commercial QC stability regulations (FDA, EMA, ICH)
  • General experience in data analysis and statistical evaluation/data trending

Responsibilities

  • Managing routine operations of the cell banks, critical intermediates, Drug Substance and Drug Product. Clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs. In addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems, handling stability Quality Events, performing stability testing, delivering stability documents.
  • Draft and revises stability protocols and reports, from initiation to finalization
  • Creates and maintains stability schedules for GMP clinical stability studies, ensuring stability samples get pulled within appropriate timeline
  • Coordinate with external testing labs to retrieve stability testing data and timepoint reports
  • Initiate, document and address stability quality events, including change controls, deviations, and analytical investigations.
  • Update stability related GMP documents (specifications, JoS, memos, etc.)
  • Performs initiation and management of stability studies in LIMS and performs data entry and review.
  • Support continuous improvement activities for stability program.
  • Provide support to applicable stability sections of regulatory submissions.
  • Present stability program updates to the Leadership Team.
  • Perform stability data trending, as needed.
  • Periodically review and update stability SOPs.

FAQs

What are the key responsibilities of a Senior Scientist in the Labs QC Stability role?

The key responsibilities include managing routine operations of cell banks, critical intermediates, Drug Substance, and Drug Product, overseeing clinical GMP stability programs, drafting and revising stability protocols and reports, creating and maintaining stability schedules, coordinating with external testing labs, initiating and addressing stability quality events, updating stability related GMP documents, performing data entry and review in LIMS, supporting continuous improvement activities for stability program, providing support to regulatory submissions, presenting stability program updates to the Leadership Team, performing stability data trending, and reviewing and updating stability SOPs.

What education and experience are required for a Senior Scientist in the Labs QC Stability role?

A Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar is required. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or a Masters degree is preferred. An equivalency of a combination of appropriate education, training, and/or directly related experience may also be considered sufficient.

What knowledge, skills, and abilities are needed to succeed in a Senior Scientist in the Labs QC Stability role?

Past experience with Quality Control, preferably with a focus on stability, a good understanding of cGMP, GDP, and GLP regulations and guidelines, knowledge of clinical and commercial QC stability regulations (FDA, EMA, ICH), and general experience in data analysis and statistical evaluation/data trending are essential for success in this role.

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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.