Associate Principal Scientist, Biologics Process R&D

Position Summary 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. 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 ensure that cell line development and cell bank characterization data packages are scientifically sound and suitable to support global regulatory submissions, serving as a key interface between Cell Line Development, Regulatory CMC, and cross‑functional CMC program teams. Key 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 packages to support the establishment of a control strategy for commercial manufacturing processes. 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. Required Qualifications 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. Preferred Qualifications 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. Salary and Benefits The salary range for this role is $142,400.00 - $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, healthcare insurance for employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr MSD Malaysia