Process Development Engineer III - Synthetic Process Chemistry

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer III for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will conduct synthesis of small molecule (cytotoxic or non-cytotoxic), synthetic route identification and/or optimization, process development & optimization using the principles of Quality by Design (QbD), process scale-up, and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization.

• Designing and developing scalable, robust and controlled GMP-ready processes for chemical synthesis of small-molecules. This includes purification development and establishing supporting analytical characterization techniques.
• Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc.
• Ensuring a team-based evaluation of processes by working closely with several groups such as R&D chemistry, Formulations Development, Analytical Chemistry, and Protein Biochemistry to ensure integrated program success.
• Generating robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities.
• Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to vet CDMO’s and successfully transfer processes with immediate, first-time success.
• Developing new technologies for process improvements and predictive process models, and pioneering novel at-line/in-line process analytical technologies to ensure robust processing.
• Reviewing and providing domain expertise for all regulatory submissions.
• Authoring publications, reports, tech transfer documents, regulatory support documents, patents.
• Performing long-term planning for laboratory related personnel, supplies and equipment.

• Have strong initiative and aim to complete challenging tasks and learn new technologies.
• Are capable of multi-tasking, working both independently and within a team environment.
• Have excellent interpersonal, verbal and written communication skills.
• Can think critically and demonstrate problem-solving skills.

This role requires a Ph.D. or Master’s in organic chemistry or a related field. At least 2-3 years of industrial experience post-PhD or at least 5 years of experience post-Master’s in active pharmaceutical ingredient (API) process development is preferred. Experience with small-molecules in the bioconjugates space will be highly preferable. Hands on experience with organic molecule synthesis and characterization tools such as mass spectrometry, nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, high-performance liquid chromatography (HPLC) etc. is preferred. Candidate must be well-versed with purification techniques such as crystallization, extraction, chromatography etc. Experience with solid-phase and liquid phase peptide synthesis is preferable. Proven experience in scaling-up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility is a plus. Candidate should be well-versed with International Council for Harmonization (ICH)/regulatory guidelines and their impact on process development of synthetic molecules and bioconjugates. Experience in working with multi-functional Chemistry, Manufacturing and Control (CMC) teams and experience in authoring publications, reports, tech transfer documents, regulatory support documents, patents is a plus.

Note: title will be commensurate with experience

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.