Process Development Engineer I - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
$80,300–$131,100 year
On-site · Tarrytown, New York, United States
Job Summary
Process Development Engineer I in Regeneron’s Synthetic and Bioconjugation Scale-up Technologies group drives GMP-ready, scalable processes for synthetic small molecules from bench to clinic. Responsibilities include designing and optimizing manufacturing processes, partnering with analytical teams for characterization, performing DOE to optimize reaction parameters and purification steps, transferring processes to CDMOs for GMP production, developing at-line/in-line process analytics, authoring transfer and regulatory documents, and mentoring junior staff. The role emphasizes collaboration across cross-functional teams, adherence to safety and regulatory expectations (FDA/DoT), and delivering robust, scalable technology ready for GMP manufacturing.
Required Qualifications
- Bachelor’s degree with 4+ years relevant experience in API process development OR Master’s degree with 0-3 years relevant experience in API process development
- Experience with small-molecule bioconjugates is highly preferable
- Hands-on experience with organic molecule synthesis and characterization tools (MS, NMR, IR, HPLC)
- Proven experience in scaling-up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility
- Familiarity with ICH/regulatory guidelines and their impact on process development of synthetic molecules and bioconjugates
- Experience collaborating with cross-functional CMC teams and authoring documents for tech transfer, regulatory support, and patents
- Strong communication skills and ability to present data clearly to broad audiences
- Experience with DOE for process optimization
- Knowledge of PAT development and at-line/in-line analytics
- On-site manufacturing and GMP compliance experience
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