Associate Director, Drug Substance Process Development

Invivyd is seeking an Associate Director, Drug Substance Process Development to oversee and execute drug substance process development activities at Contract Manufacturing Organizations (CMOs). The ideal candidate will have strong expertise in drug substance development, particularly in downstream purification process development, and experience with external manufacturing oversight, technology transfer, and late-stage/commercial readiness.

Requirements

• BS/MS in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or related scientific discipline
• 10–15 years of experience in biopharmaceutical or biotechnology industry
• Demonstrated experience in drug substance process development for biologics, with strong emphasis on downstream purification development
• Proven track record in process scale-up, process characterization, and development of control strategies
• Extensive experience leading and supporting technology transfer to CDMOs
• Strong knowledge of cGMP principles, ICH guidelines (Q8–Q11), and global regulatory expectations
• Experience supporting CMC regulatory filings
• Strong communication and leadership skills

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Relocation Assistance