Associate Director, Drug Substance Manufacturing – Upstream Process
$175,000–$210,000 year
On-siteBrisbane, California, United States
Job Summary
Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing upstream activities. Lead investigations for technical deviations, root cause analyses, and CAPA implementation while supervising campaign readiness, change management, and process optimization discussions. Oversee technology transfer and process qualification across CMO sites, author and review validation protocols, and drive continuous improvement initiatives. Perform statistical analysis on campaign data to create process trends and control charts, establishing robust Continuous Process Verification protocols. Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA) and support responses to health authority questions. Manage timelines, supply impact, risks, and budget for internal technical meetings, ensuring strategies align with GMP, ICH, and global regulatory expectations.
Required Qualifications
- MS in relevant life sciences or engineering discipline
- minimum of 5 years of Pharmaceutical/Biotechnology industry experience
- BS with 8 years of experience
- experience in biologics drug substance upstream processes
- experience in technology transfer
- experience in cGMP manufacturing operations
- Extensive hands-on experience in upstream processing
- experience in cell bank management
- experience in cell culture (expansion and production)
- experience in harvest
- Working knowledge of technology transfer
- Working knowledge of process validation
- routine management of GMP manufacturing
- Experience in managing US/international CDMOs
- Proven leadership and cross-functional management of CMC-related programs
- Track record of successfully driving and managing programs
- ability to overcome challenges
- ability to manage risks
- Critical thinking and problem-solving skills
- ability to drive risk-based decision making
- Strong organizational and project management skills
- proficient use of MS Project
- Excellent communication and interpersonal skills
Desired Qualifications
- Experience in process development and/or manufacturing sciences and technology (MSAT)
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