Associate Principal Scientist, Biologics Process R&D

Merck • Rahway, NJ

4d • $142,400 - $224,100

About The Position

We are seeking a highly motivated and experienced Associate Principal Scientist to join our Cell Line Development group. The successful candidate will also 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. The ideal candidate will have strong hands-on and strategic experience with mammalian cell line development, late-stage CMC program support, regulatory filing authoring, and limit of in vitro cell age (LIVCA) studies. The candidate will be responsible for ensuring that cell line development and cell bank characterization data packages are scientifically sound, and suitable to support global regulatory submissions. This role will serve as a key interface between Cell Line Development, Regulatory CMC, and cross-functional CMC program teams.

Requirements

• Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related discipline with 4+ years of industry experience; or 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.

Nice To Haves

• Experience supporting global regulatory submissions across major markets, including the United States, Europe, Japan and China.
• Experience in upstream commercial process development for biologics programs.
• Hands-on experience with cell line genetic characterization techniques including RNAseq, PCR, Southern and Northern blotting.
• Experience preparing technical source documents, regulatory summaries, RTQs, and agency briefing materials.
• Experience across early and late-stage biologics development, with an ability to connect CLD decisions into long-term regulatory and commercial strategy.

Responsibilities

• Lead and support cell line development and cell bank characterization activities for late-stage biologics programs.
• Design and execute pre-LIVCA studies, coordinate LIVCA campaigns and generate genetic stability data package to support establishment of control strategy for commercial manufacturing process. Partner with Upstream, Downstream, Analytical and Manufacturing teams.
• Author, review, and provide technical input for CLD-related sections of regulatory submissions, including IND, IMPD, BLA and MAA submissions, and responses to global regulatory agencies.
• Serve as the CLD representative on cross-functional CMC teams and partner closely with Regulatory CMC to develop scientifically robust filing strategies.
• Support responses to health authority questions (RTQs) related to cell line development, cell banking, clonality, genetic stability, LIVCA, and related control strategy topics.
• Author technical reports, source documents, risk assessments, and knowledge management content related to cell line development. Support digitization efforts to streamline authoring and report writing.
• Maintain awareness of relevant regulatory expectations, industry practices, and scientific developments related to cell line development, cell bank characterization, and LIVCA.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree