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.

• 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

• 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.

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