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.