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.

#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 employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)