Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking Staff Engineer for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will provide scientific leadership for small molecule (cytotoxic or non-cytotoxic) synthetic process chemical development using the principles of Quality by Design (QbD), process scale-up, and technology transfer of manufacturing-related workflows at Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic through product commercialization.
A Typical Day in the role of Staff Engineer Might Include:
This role may be for you if you:
- Designing and developing scalable, robust and controlled cGMP-ready processes for the chemical synthesis, purification, and isolation of small molecules.
- 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, CDMOs, and other key partners 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 Regenerons Industrial Operations and Product Supply (IOPS) organization to vet CDMOs and successfully transfer processes with immediate, first-time success.
- Promote new technologies for process improvements, predictive process models, and novel at-line/in-line process analytical technologies to ensure robust processing.
- Reviewing and providing domain expertise for regulatory submissions.
- Authoring publications, reports, tech transfer documents, regulatory support documents, patents.
- Scientifically up-to-date on advances in process chemistry and related fields
- Requires up to 20% travel
- 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 Masters in organic chemistry or a related field. At least 5 years of industrial experience post-PhD or at least 7 years of experience post-Masters 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.
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Career Development in PMPD Video:
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$121,200.00 - $197,800.00