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

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. Experience 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.

 

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$80,300.00 - $131,100.00