Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2)
Regeneron
June 30, 2026
On-site
Tarrytown, NY
Operations
Process Development Associate (Process Development Associate II)
Role responsibilities:
- Work at the bench to design and develop scalable, robust, GMP-ready bioconjugation and purification processes.
- Collaborate with analytical groups to establish analytical characterization techniques.
- Present plans and data in cross-functional teams to evaluate processes and define developmental goals.
- Follow lab safety and environmental safety expectations and applicable regulatory requirements (e.g., FDA, DOT).
- Use statistical design of experiments (DOE) to optimize conjugation reactions, purification operations, and analytical characterization.
- Partner with external manufacturing and internal manufacturing teams to assess CDMOs for GMP production and transfer processes with first-time success.
- Research and develop new technologies to improve processes, build predictive process models, and pioneer at-line/in-line PAT.
- Author technology transfer documentation and support onsite during scale-up/GMP manufacturing.
- Analyze and present data for data-driven decision making.
- Author/review technical documents, tech transfer materials, regulatory support documents, and patents; provide domain expertise.
- Maintain lab equipment, ensure a tidy/organized lab, plan for lab resources; coach junior team members.
Qualifications/required:
- Bachelor’s degree + 0–3 years relevant experience in chemical/biochemical engineering or related field.
Preferred skills/experience:
- Antibodies experience in the bioconjugates space.
- Hands-on bioconjugation experience (lysine-based, cysteine-based, site-specific, etc.) and downstream purification (chromatography, ultrafiltration/diafiltration, membrane technologies).
- Experience with analytical tools (electrophoresis, mass spectrometry, HPLC, UV spectroscopy).
Application instructions:
- Apply now.
Role responsibilities:
- Work at the bench to design and develop scalable, robust, GMP-ready bioconjugation and purification processes.
- Collaborate with analytical groups to establish analytical characterization techniques.
- Present plans and data in cross-functional teams to evaluate processes and define developmental goals.
- Follow lab safety and environmental safety expectations and applicable regulatory requirements (e.g., FDA, DOT).
- Use statistical design of experiments (DOE) to optimize conjugation reactions, purification operations, and analytical characterization.
- Partner with external manufacturing and internal manufacturing teams to assess CDMOs for GMP production and transfer processes with first-time success.
- Research and develop new technologies to improve processes, build predictive process models, and pioneer at-line/in-line PAT.
- Author technology transfer documentation and support onsite during scale-up/GMP manufacturing.
- Analyze and present data for data-driven decision making.
- Author/review technical documents, tech transfer materials, regulatory support documents, and patents; provide domain expertise.
- Maintain lab equipment, ensure a tidy/organized lab, plan for lab resources; coach junior team members.
Qualifications/required:
- Bachelor’s degree + 0–3 years relevant experience in chemical/biochemical engineering or related field.
Preferred skills/experience:
- Antibodies experience in the bioconjugates space.
- Hands-on bioconjugation experience (lysine-based, cysteine-based, site-specific, etc.) and downstream purification (chromatography, ultrafiltration/diafiltration, membrane technologies).
- Experience with analytical tools (electrophoresis, mass spectrometry, HPLC, UV spectroscopy).
Application instructions:
- Apply now.