Process Development Engineer I - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
Regeneron
August 16, 2026
On-site
Tarrytown, NY
Operations
What You'll Do:
- Work at the bench to design and develop scalable, robust, controlled GMP-ready processes for synthetic small molecules.
- Collaborate with analytical groups to establish analytical characterization of synthetic intermediates and final products.
- Discuss plans and data in cross-functional teams to evaluate processes and define developmental goals.
- Use statistical design of experiments (DOE) to optimize synthetic chemical processes (reaction parameters, purification operations, analytical characterization).
- Partner with External Manufacturing to assess intended GMP CDMOs and transfer processes with immediate, first-time success.
- Research and develop new technologies; generate predictive process models; develop at-line/in-line process analytical technologies (PAT).
- Author technology transfer documentation and support production during scale-up/GMP manufacturing.
- Analyze and present data for data-driven decisions.
- Author/review technical publications, reports, tech transfer and regulatory support documents, and patents.
- Coach and mentor junior team members.
Must-haves / Qualifications:
- BS with 4 years, or MS with 0–3 years, in API process development.
- Initiative and drive to learn new technologies.
- Strong process chemistry and technology transfer fundamentals.
- Excellent communication and critical thinking/problem-solving.
- Knowledge of purification techniques (crystallization, extraction, chromatography).
Preferred / Nice-to-haves:
- Small-molecule bioconjugates experience.
- Organic synthesis and characterization (MS, NMR, IR, HPLC).
- Scale-up and GMP tech transfer experience.
- Experience with highly potent compounds containment.
- Familiarity with ICH/regulatory guidelines.
- CMC cross-functional experience; authoring tech/regulatory/patent documents.
Benefits:
- Student Loan Paydown & Tuition Reimbursement; Family Care Benefits; Relocation Assistance; Inclusion/Culture & Well-Being programs.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.
- Work at the bench to design and develop scalable, robust, controlled GMP-ready processes for synthetic small molecules.
- Collaborate with analytical groups to establish analytical characterization of synthetic intermediates and final products.
- Discuss plans and data in cross-functional teams to evaluate processes and define developmental goals.
- Use statistical design of experiments (DOE) to optimize synthetic chemical processes (reaction parameters, purification operations, analytical characterization).
- Partner with External Manufacturing to assess intended GMP CDMOs and transfer processes with immediate, first-time success.
- Research and develop new technologies; generate predictive process models; develop at-line/in-line process analytical technologies (PAT).
- Author technology transfer documentation and support production during scale-up/GMP manufacturing.
- Analyze and present data for data-driven decisions.
- Author/review technical publications, reports, tech transfer and regulatory support documents, and patents.
- Coach and mentor junior team members.
Must-haves / Qualifications:
- BS with 4 years, or MS with 0–3 years, in API process development.
- Initiative and drive to learn new technologies.
- Strong process chemistry and technology transfer fundamentals.
- Excellent communication and critical thinking/problem-solving.
- Knowledge of purification techniques (crystallization, extraction, chromatography).
Preferred / Nice-to-haves:
- Small-molecule bioconjugates experience.
- Organic synthesis and characterization (MS, NMR, IR, HPLC).
- Scale-up and GMP tech transfer experience.
- Experience with highly potent compounds containment.
- Familiarity with ICH/regulatory guidelines.
- CMC cross-functional experience; authoring tech/regulatory/patent documents.
Benefits:
- Student Loan Paydown & Tuition Reimbursement; Family Care Benefits; Relocation Assistance; Inclusion/Culture & Well-Being programs.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.