Associate Principal Scientist, Biologics Process R&D

We are seeking a highly motivated and experienced Associate Principal Scientist to join our Cell Line Development group. The successful candidate will provide scientific and technical leadership for late-stage biologics programs with a focus on cell line development and cell banking-related regulatory strategy, filing authoring, and health authority response support.

Requirements

• Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related discipline with 4+ years of industry experience
• Master’s degree with 8+ years of industry experience
• Strong experience in mammalian cell line development, preferably using CHO-based expression systems for therapeutic proteins or monoclonal antibodies
• Working knowledge of ICH guidelines and regulatory expectations relevant to biotechnology-derived products, cell substrates, cell banking, and genetic stability
• Demonstrated experience supporting late-stage biologics programs, including pre-LIVCA studies to generate both phenotypic and genotypic stability data packages
• Experience authoring CLD-related regulatory submissions and supporting responses to health authority questions in collaboration with Regulatory CMC teams and cross-functional CMC development teams
• Strong scientific writing and communication skills, with the ability to develop clear, accurate, and well-structured technical and regulatory documents
• Strong understanding of cell line history, clone selection, clonality, cell substrate characterization, cell bank generation & testing, genetic stability, and LIVCA
• Ability to work independently, manage multiple priorities, and influence cross-functional teams effectively

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days