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 in the Role of Process Development Engineer III 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
- Posses 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.
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. 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.
#pmpdSalary Range (annually)$109,900.00 - $179,300.00
