Senior Process Engineer
Listed on 2026-02-28
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Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Validation Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Validation Engineer
Hiring:
Senior Process Engineer – Biologic Drug Substance / Technology Transfer (Engineering Project Lead)
We are seeking an experienced Senior Process Engineer to support biologics drug substance technology transfers across early-stage development through commercial manufacturing within CMC. This role serves as a technical subject matter expert, partnering with process development, clinical supply, quality, regulatory, and global manufacturing teams to ensure successful GMP-compliant manufacturing and process readiness.
Candidates near New Haven, CT may be considered if fully onsite
Duration: 12 months
Key Responsibilities- Lead and support biologics drug substance technology transfer activities across development and commercialization
- Serve as technical subject matter expert for GMP manufacturing and process validation
- Develop and improve tech transfer standards, SOPs, and operational tools
- Support regulatory submissions including IND, IMPD, BLA, and MAA
- Develop and implement raw material control strategies and specifications
- Review technical protocols, manufacturing records, and quality documentation
- Monitor manufacturing performance and drive continuous improvement initiatives
- Collaborate with cross functional and global manufacturing teams
- Degree in Engineering or Life Sciences such as Chemical, Biochemical, Mechanical, Biology, or Chemistry
- PhD, or MS with 6 or more years, or BS with 8 or more years of relevant experience
- Strong experience in biologics or biopharmaceutical manufacturing
- Knowledge of GMP manufacturing and process validation
- Experience with drug substance unit operations including cell culture, centrifugation, filtration, UF DF, and chromatography
- Ability to support manufacturing sites including travel of approximately 25 percent and cleanroom presence
- Experience establishing raw material control strategies with regulatory agencies
- Continuous improvement experience
- Basic statistical analysis knowledge
- Strong cross functional collaboration and influence skills
If you have strong biologics manufacturing and technology transfer experience and are interested in a high impact engineering role, we would like to connect.
Apply or message me directly to learn more.
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