Principal Scientist, Drug Substance Process Development & Manufacturing
Related skills
gmp purification upstream downstream📋 Description
- Support DS process development and manufacturing (upstream, purification, clearance)
- Design/execute scale-up, process characterization, and PPQ studies
- Own tech transfer and CDMO GMP campaigns (on-site support as needed)
- Review GMP docs including batch records, deviations, CAPAs
- Provide technical leadership for GMP manufacturing and data-driven decisions
- Cross-functional collaboration with CMC/QA/Regulatory/Supply Chain
🎯 Requirements
- PhD or MS in Chemical Engineering, Biochemistry, or related field
- 5–8 years of industry experience in DS development and/or GMP manufacturing
- Strong attention to detail and ability to analyze complex technical data
- Excellent communication and strong technical writing skills
- Experience with CDMOs, tech transfer, and regulatory submissions
- GMP documentation experience and QA systems (deviations, change control, CAPA)
🎁 Benefits
- Hybrid work with 1–2 days/week in Somerville office
- Collaborative cross-functional team in Generative Biology
- Exposure to late-stage CMC activities and CDMO partnerships
- Use AI-driven tools for knowledge management and data analysis
- Global biopharma environment with growth opportunities
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