Process Development Engineer I - Synthetic and Bioconjugation Scale-Up Technologies (SBST)

About the role

We are seeking a Process Development Engineer I to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical Manufacturing & Process Development (PMPD) department. In this exciting new role, you will develop manufacturing processes for the production of synthetic small-molecules used in Regeneron's diverse range of therapeutic modalities. You would work in close collaboration with cross-functional teams performing chemical process development and optimization using the principles of Quality by Design (QbD) to deliver processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic and eventual commercialization. A typical day in the role of a Process Development Engineer I might include: Working at the bench to design and develop scalable, robust and controlled GMP-ready processes for synthetic small molecules. Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization of synthetic intermediates and final products. Discussing plans and data in multi-functional teams to evaluate processes and determine developmental goals and ensure integrated program success. Proactively complying with lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc. Using statistical design of experiments (DOE) to optimize synthetic chemical processes including reaction parameters, purification operations, and analytical characterization. Partnering with External Manufacturing group and other key partners at Regeneron's IOPS organization to provide technical assessment of CDMOs intended for GMP production and successfully transferring processes with immediate, first-time success. Researching, identifying, and developing new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT) to ensure robust and controllable synthetic processes. Authoring robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities. Analyzing and presenting data in a clear and cohesive manner to a broad audience facilitating data-driven decision making. Authoring, reviewing, or providing domain expertise for publications, reports, tech transfer documents, regulatory support documents and patents. Being a responsible lab citizen by ensuring timely maintenance of lab equipment, keeping the lab tidy and organized and proactively planning for lab resources. Coaching and mentorship of junior team members of the organization as needed. This Role May be for You If You: Enjoy working in the lab to advance exciting new drug modalities to patients Have strong initiative and aim to complete challenging tasks and learn new technologies Have a strong fundamental understanding of various process chemistry and technology transfer principles Are capable of multi-tasking and working both independently and in a collaborative environment involving cross-functional teams. Have excellent interpersonal, verbal and written communication skills Can think critically and demonstrate problem-solving skills This role requires a Bachelor's + 4 years relevant experience or Master's +0-3 years relevant experience in active pharmaceutical ingredient (API) process development. 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. Proven experience in scaling-up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility is a plus. E xperience in handling highly potent compounds using appropriate containment and best‑practice procedures 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 cross-functional Chemistry, Manufacturing and Control (CMC) teams and experience in authoring publications, reports, tech transfer documents, regulatory support documents, patents is a plus. #pmpd Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employme

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