Process Development Engineer III, Analytical Science: Synthetic and Bioconjugation Scale-Up Technologies (SBST)

About the Role

Regeneron's Preclinical Manufacturing & Process Development (PMPD) organization in Tarrytown, NY is seeking a highly motivated Process Development Engineer III to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) Analytics group. In this role, you will serve as the analytical lead to develop fit-for-purpose analytical methods, transfer, and provide troubleshooting support to advance diverse bioconjugate pipeline. You will lead and implement analytical deliverables working closely with bioconjugation teams and internal/external collaborators (CDMOs) to advance bioconjugate programs from development to commercialization.

A Typical Day Might Look Like

• Independently design and execute analytical testing, method development and characterization to enable bioconjugate process development.
• Serve as the subject matter expert to lead and design analytical deliverables: robust method development, method transfer to internal/external receiving labs, training, and troubleshooting to move program forward.
• Connect, interpret, communicate complex results into clear actionable next steps to technical and non-technical audiences to persuade and drive timely decisions.
• Author high-quality documentation (i.e., procedures, development and characterization reports, ELN entries) in a timely manner to support program timelines.
• Drive, build and improve business workflows: documentation standardization, data digitization, and sample management.
• Maintain compliance with lab and environmental safety requirements and promote a safe lab environment.
• Proactively scout, evaluate, and implement new or improved technologies for high-throughput analytics and real-time decision making.
• Lead equipment upkeep, troubleshooting, maintain an organized workspace, and proactively plan for lab resources.
• Mentor and support peers and junior team members (direct and/or indirect via matrix).

This Role May Be For You If You

• Enjoy working in the lab to advance exciting new drug modalities to patients.
• Possess strong initiative and aim to complete challenging tasks and learn new technologies quickly.
• Possess strong hands-on experience and fundamental understanding of analytical techniques and method development for antibody, bioconjugates, and/or synthetic molecule (small molecule, peptides, and oligos) characterization, including relevant software.
• Lead with customer centric mindset with providing analytical support to advance drug development in different phases of the program.
• Thrive in a fast-paced, highly collaborative environment working on complex problems.
• Communicate clearly (written and verbal), simplify messages for impact, and build strong working relationships.
• Think critically and apply strong problem-solving skills, and comfortable navigating ambiguity.

Requirements

This role requires a B.S. with 10+ years of relevant experience, or M.S. with 7+ years or recent PhD with 0-3 years of relevant experience in chemistry, biochemistry, biology, chemical engineering, or a related field.

Qualifications

• Hands-on experience with analytical method development for antibody, bioconjugate, and/or synthetic molecules (e.g., small molecule, PEG, peptides, and/or siRNA) such as electrophoresis, HPLCs, LC-MS, UV spectroscopy, plus associated software (e.g., Empower).
• Hands-on experience in transferring methods to internal/external labs, and troubleshooting.
• Demonstrated experience serving as an analytical lead for bioconjugate programs, collaborating effectively with internal teams and external CDMOs.
• Strong written and verbal communication skills, including the ability to present data clearly to diverse audiences.
• Experience drafting analytical methods, development and characterization reports to support regulatory filing.
• Ability to work independently and collaboratively across cross-functional teams to persuade and drive data-based decision.
• Demonstrated initiative, learning agility, and a growth mindset in a fast-paced environment.