Senior Scientist - Stability Testing, GMP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Reporting to the Associate Director, CMC QC Stability, will be responsible for managing routine operations of the cell banks, critical intermediates, Drug Substance and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs, internal policies and industry guidance. In addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems, including handling stability Quality Events, performing stability testing, delivering stability documents and coordinating with external resources (CTOs, CMOs, etc.).

Key responsibilities:

• 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, as required
• Update stability related GMP documents (specifications, JoS, memos, etc.)
• Performs initiation and management of stability studies in LIMS and performs data entry and review, as required.
• Support continuous improvement activities for VCGT stability program
• Provide support to applicable stability sections of regulatory submissions
• Present stability program updates to the cross-functional group, as needed
• Perform stability data trending, as needed
• Periodically review and update stability SOPs

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Pharmaceutical Science, Immunology, Biology, Molecular Biology or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years)

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
• Ability to interact effectively within the organization and externally with CTOs and CMOs

  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.

  Benefits

  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!