Job Description
Overview Role Summary We're looking for a Principal Scientist through Director, Drug Product Development to lead development of protein drug product formulations and presentations, drive manufacturing process readiness, and manage technical transfer and production execution at external CDMO partners. The role is accountable for ensuring a reliable, compliant drug product supply to support clinical trials and eventual commercial launch. This position calls for strong hands-on and strategic experience in lyophilization development, aseptic processing, and CMC/regulatory documentation, along with the ability to align internal stakeholders and external manufacturing partners. As the drug product leader within the CMC organization, this individual will act as the primary technical authority for drug product manufacturing and provide direction across cross-functional teams to advance programs from development through commercialization. The role partners closely with Drug Substance Development, Regulatory, Quality, and Supply Chain to coordinate execution, timelines, and readiness. Responsibilities Key Responsibilities Own and direct all drug product activities, including formulation development, lyophilization cycle/process development, technology transfer, GMP manufacturing, and drug product release support Serve as the drug product technical expert, offering scientific leadership and decision-making support across matrixed teams Define drug product strategy for late-stage development and commercial launch, including manufacturing network and control strategy considerations Lead and oversee drug product tech transfer and GMP manufacturing at CDMOs, including on-site {"person-in-plant") support as needed Manage COMO performance against scope, timelines, and deliverables, in close collaboration with Quality and Technical Operations Ensure phase-appropriate execution for scale-up, process characterization, process validation readiness, PPQ planning/execution, and overall commercial preparedness Apply QbD and risk-based approaches to define development plans, process understanding, and control strategies Review manufacturing data, trend outcomes, and drive continuous improvement/optimization opportunities Support formulation for protein therapeutics as programs evolve Partner with Quality and COMOs to review batch records, support investigations, and resolve deviations/quality events Write, review, and contribute to CMC content for IND/IMPD/BLA, briefing packages, and other regulatory filings Qualifications Ideal Candidate 10+ years of industry experience in biologics drug product development and manufacturing 5+ years supporting GMP operations for lyophilized drug products, with demonstrated ability to maintain compliance and operational execution across clinical and/or commercial stages Track record of leadership in GMP manufacturing environments (direct and/or matrix leadership) PhD in a relevant scientific/engineering field (or equivalent combination of education and experience) Deep expertise in aseptic drug product process development and manufacturing, ideally with protein products Experience leading COMO relationships, including tech transfer, routine oversight, and manufacturing campaign execution Demonstrated experience supporting PPQ and commercialization activities for Strong cross-functional collaboration skills across Drug Substance, Analytical, Device/Combination Product (if applicable), Clinical/Clin Ops, Supply Chain, Quality, and Regulatory Clear, concise communicator able to translate technical issues for diverse audiences and drive alignment Comfortable coordinating across global time zones Willingness to travel - including domestic and international sites Salary range: $170,000 -$190,000 Sequel Pharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, gender identification, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.