Principal Scientist, Drug Substance Process Development 6 Manufacturing (mAB development focus)

📋 Description

• Support Drug Substance process development and manufacturing activities (e.g., upstream expression, purification, UF/DF, viral clearance)
• Design and execute scale-up, process characterization, and PPQ-enabling studies
• Own tech transfer and support GMP campaigns at CDMO (person-in-plant support as needed)
• Review and/or author GMP documentation including batch records, change controls, deviations and CAPAs
• Provide technical leadership for GMP manufacturing, including troubleshooting and data-driven decision making
• Partner cross-functionally across CMC, QA, Regulatory, and Supply Chain to drive program execution

🎯 Requirements

• PhD or MS in Chemical Engineering, Biochemistry, or related field with relevant industry experience in biologics manufacturing
• 58 years of industry experience in Drug Substance process development and/or GMP manufacturing in a biotech/pharma setting
• Strong attention to detail with the ability to analyze complex technical data
• Excellent communication and strong technical writing skills
• Experience working with CDMOs, supporting tech transfer, and regulatory submissions
• Hands-on experience with GMP documentation (eg: executed Batch Records) and quality systems (deviations, change control, CAPA)

🎁 Benefits

• Opportunity to contribute to the development of innovative biologics and work with cross-functional teams
• Exposure to late-stage CMC activities and collaboration with leading CDMOs
• Focus on data integrity, robust documentation, and scalable workflows