Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2)
Regeneron
11 hours ago
On-site
Tarrytown, NY
Operations
Process Development Associate (SBST) — Tarrytown, NY
Responsibilities:
- Design and develop scalable, robust, controlled GMP-ready bioconjugation and purification processes.
- Collaborate with analytical groups to establish analytical characterization techniques.
- Present plans/data in cross-functional teams to evaluate processes and set developmental goals.
- Comply with lab and environmental safety expectations (e.g., FDA, DOT).
- Use statistical DOE to optimize bioconjugation (conjugation reactions, purification operations, and analytics).
- Partner with external manufacturing/IOPS teams to assess CDMOs for GMP production and transfer processes with first-time success.
- Research and develop new technologies, predictive process models, and at-line/in-line PAT.
- Author technology transfer documentation and support scale-up/GMP manufacturing with onsite presence.
- Analyze/present data clearly to broad audiences; author/review publications, reports, tech transfer/regulatory/patent documents.
- Maintain lab equipment, keep lab organized, and plan for lab resources; coach/mentor junior team members as needed.
Qualifications:
- Bachelor’s + 0–3 years relevant experience in chemical/biochemical engineering or related field.
- Highly preferable: experience with antibodies in the bioconjugates space.
- Preferred: hands-on bioconjugation processes (lysine-based, cysteine-based, site-specific) and downstream purification (chromatography, UF/DF, membrane technologies).
- Preferred: analytical characterization tools (electrophoresis, mass spectrometry, HPLC, UV spectroscopy, etc.).
Application instructions:
- “Does this sound like you? Apply now.”
Salary/benefits:
- Benefits and salary range are described in the posting (salary range: $70,300.00–$110,100.00).
Responsibilities:
- Design and develop scalable, robust, controlled GMP-ready bioconjugation and purification processes.
- Collaborate with analytical groups to establish analytical characterization techniques.
- Present plans/data in cross-functional teams to evaluate processes and set developmental goals.
- Comply with lab and environmental safety expectations (e.g., FDA, DOT).
- Use statistical DOE to optimize bioconjugation (conjugation reactions, purification operations, and analytics).
- Partner with external manufacturing/IOPS teams to assess CDMOs for GMP production and transfer processes with first-time success.
- Research and develop new technologies, predictive process models, and at-line/in-line PAT.
- Author technology transfer documentation and support scale-up/GMP manufacturing with onsite presence.
- Analyze/present data clearly to broad audiences; author/review publications, reports, tech transfer/regulatory/patent documents.
- Maintain lab equipment, keep lab organized, and plan for lab resources; coach/mentor junior team members as needed.
Qualifications:
- Bachelor’s + 0–3 years relevant experience in chemical/biochemical engineering or related field.
- Highly preferable: experience with antibodies in the bioconjugates space.
- Preferred: hands-on bioconjugation processes (lysine-based, cysteine-based, site-specific) and downstream purification (chromatography, UF/DF, membrane technologies).
- Preferred: analytical characterization tools (electrophoresis, mass spectrometry, HPLC, UV spectroscopy, etc.).
Application instructions:
- “Does this sound like you? Apply now.”
Salary/benefits:
- Benefits and salary range are described in the posting (salary range: $70,300.00–$110,100.00).