Sr Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies

Responsibilities

• Provide scientific leadership for synthetic oligonucleotide process development using Quality by Design (QbD) principles.
• Design and develop scalable, robust, and controlled GMP-ready processes for the chemical synthesis and purification of small-molecules and oligonucleotides.
• Manage process scale-up and technology transfer to Contract Development and Manufacturing Organizations (CDMOs).
• Partner with cross-functional teams including R&D Chemistry, Formulations, Analytical Chemistry, and Protein Biochemistry.
• Author technical documentation, including publications, reports, tech transfer documents, and regulatory support materials.
• Develop new technologies for process improvements, including predictive models and novel at-line/in-line process analytical technologies.
• Review and provide domain expertise for regulatory submissions.

Requirements

• Ph.D. or Master’s degree in Organic Chemistry or a related field.
• Extensive industrial experience in Active Pharmaceutical Ingredient (API) process development (7-8+ years post-PhD or 12+ years post-MS preferred).
• Hands-on experience with organic molecule synthesis and characterization tools such as MS, NMR, IR, and HPLC.
• Proficiency in purification techniques including crystallization, extraction, and chromatography.
• Strong knowledge of ICH and regulatory guidelines and their impact on process development.
• Proven ability to work independently and within a multi-functional team environment.

Preferred Qualifications

• Experience with small-molecules in the bioconjugates space.
• Experience with solid-phase and liquid-phase peptide synthesis.
• Proven track record in scaling up synthetic reactions and technology transfer to GMP manufacturing facilities.
• Experience working with multi-functional Chemistry, Manufacturing, and Control (CMC) teams.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, the company focuses on translating science into medicine to treat eye diseases, cancer, cardiovascular diseases, and rare diseases.