Process Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
Regeneron
August 31, 2026
On-site
Tarrytown, NY
Operations
Discover Your Role
- Works at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes
- Collaborates with analytical groups to establish analytical characterization techniques
- Discusses plans and data in cross-functional teams to evaluate processes and determine developmental goals
- Proactively complies with lab safety and environmental safety expectations (e.g., FDA and DOT)
- Uses statistical design of experiments (DOE) to optimize bioconjugation processes, including conjugation, purification, and analytics
- Partners with External Manufacturing/IOPS to assess CDMOs and transfer processes with immediate first-time success
- Researches and develops new technologies to improve processes, generate predictive models, and pioneer novel at-line/in-line PAT
- Authors technology transfer documentation and supports production onsite during scale-up/GMP manufacturing
- Analyzes and presents data clearly to enable data-driven decision making
- Authors/reviews technical and regulatory documents and supports publications/patents
- Maintains lab equipment, keeps lab organized, and plans for lab resources
- Coaches and mentors junior team members as needed
This Role Requires
- Bachelor’s degree + 5–6 years (or Master’s + 3–4 years) in chemical/biochemical engineering or related field
- Antibodies experience in the bioconjugates space (highly preferable)
- Hands-on bioconjugation (lysine/cysteine/site-specific) and downstream purification (chromatography, UF/DF, membranes) (preferred)
- Analytical characterization experience (electrophoresis, MS, HPLC, UV spectroscopy) (preferred)
- Strong initiative; fundamental protein purification and technology transfer knowledge
- Ability to multi-task and work independently and cross-functionally
- Excellent communication and strong critical thinking/problem-solving skills
- Works at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes
- Collaborates with analytical groups to establish analytical characterization techniques
- Discusses plans and data in cross-functional teams to evaluate processes and determine developmental goals
- Proactively complies with lab safety and environmental safety expectations (e.g., FDA and DOT)
- Uses statistical design of experiments (DOE) to optimize bioconjugation processes, including conjugation, purification, and analytics
- Partners with External Manufacturing/IOPS to assess CDMOs and transfer processes with immediate first-time success
- Researches and develops new technologies to improve processes, generate predictive models, and pioneer novel at-line/in-line PAT
- Authors technology transfer documentation and supports production onsite during scale-up/GMP manufacturing
- Analyzes and presents data clearly to enable data-driven decision making
- Authors/reviews technical and regulatory documents and supports publications/patents
- Maintains lab equipment, keeps lab organized, and plans for lab resources
- Coaches and mentors junior team members as needed
This Role Requires
- Bachelor’s degree + 5–6 years (or Master’s + 3–4 years) in chemical/biochemical engineering or related field
- Antibodies experience in the bioconjugates space (highly preferable)
- Hands-on bioconjugation (lysine/cysteine/site-specific) and downstream purification (chromatography, UF/DF, membranes) (preferred)
- Analytical characterization experience (electrophoresis, MS, HPLC, UV spectroscopy) (preferred)
- Strong initiative; fundamental protein purification and technology transfer knowledge
- Ability to multi-task and work independently and cross-functionally
- Excellent communication and strong critical thinking/problem-solving skills