Bioconjugation Process Engineer II: Scale-Up & GMP Transfer

Regeneron Pharmaceuticals; Tarrytown (GA); Vor Ort; USD 94.000 - 153.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals in Tarrytown, NY is seeking a Process Development Engineer II to join the PMPD group. You will develop conjugation and purification processes for protein bioconjugation and oversee scale-up and tech transfer to CDMOs, ensuring GMP readiness and timely progression from clinic to commercialization.

You will collaborate across functions, apply QbD principles, conduct DOE, mentor junior staff, and contribute to publications and regulatory documents while maintaining safety

Qualifikationen

• Bachelor’s degree in chemical/biochemical engineering or related field; 5–6 years of relevant experience, or Master’s with 3–4 years.
• Experience with antibodies in the bioconjugates space is highly preferable.
• Hands-on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific) with practical downstream purification knowledge.
• Experience with analytical tools such as electrophoresis, mass spectrometry, HPLC, and UV spectroscopy is preferred.

Aufgaben

• Design scalable GMP-ready bioconjugation and purification processes.
• Collaborate with analytical groups to establish characterization techniques.
• Discuss plans in cross-functional teams to evaluate processes and set developmental goals.
• Ensure compliance with lab safety and regulatory requirements (FDA/DoT).
• Use DOE to optimize bioconjugation, purification, and analytics.
• Transfer processes with CDMOs and Regeneron sites for GMP production.
• Develop new technologies to improve processes and create predictive models.
• Author tech transfer docs and support onsite during scale-up.
• Present data clearly to diverse audiences for decision making.
• Contribute to publications, reports, regulatory documents, and patents.

Kenntnisse

Bioconjugation

Purification

Analytical Techniques

DOE

Cross-functional Collaboration

Communication

Ausbildung

Bachelor's degree in chemical/biochemical engineering

Master's degree in chemical/biochemical engineering

Tools

HPLC

Mass spectrometry

Electrophoresis

UV spectroscopy

Ultrafiltration/diafiltration

Chromatography

Jobbeschreibung

Regeneron Pharmaceuticals in Tarrytown, NY is seeking a Process Development Engineer II to join the PMPD group. You will develop conjugation and purification processes for protein bioconjugation and oversee scale-up and tech transfer to CDMOs, ensuring GMP readiness and timely progression from clinic to commercialization.

You will collaborate across functions, apply QbD principles, conduct DOE, mentor junior staff, and contribute to publications and regulatory documents while maintaining safety