Related skills
process development regulatory chromatography cgmp technology transfer📋 Description
- Provide technical leadership for drug substance process development to CMOs
- Oversee technology transfer, scale-up, and process validation
- Develop downstream purification strategies, robustness, and scalability
- Support clinical and commercial manufacturing readiness and regulatory alignment
- Collaborate with Analytical Development, Quality, Regulatory, and Supply Chain to align control strategies
🎯 Requirements
- BS/MS in Chemical/Biochemical/Pharmaceutical Eng or related field
- 10–15 years in biopharma process development, scale-up, tech transfer
- Biologics drug substance development with downstream purification focus
- Lead tech transfer to CDMOs; external partnerships
- Strong knowledge of cGMP, ICH Q8–Q11, FDA/EMA expectations
- CMC regulatory filings experience (INDs/IMPDs, BLAs/MAAs)
- Willingness to travel up to 20% for tech transfer at CDMOs
- Hybrid work capacity: 1 day/week in HQ
🎁 Benefits
- Hybrid work model with weekly HQ office day
- Annual short-term incentive and long-term equity
- Equal opportunity employer
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