Cmp Process Development Engineer Jobs in New York

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Process Development Engineer I to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group, 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, working in close collaboration with cross-functional teams to perform chemical process development and optimization using Quality by Design (QbD) principles for GMP production.

This position offers the opportunity to contribute to process scale-up and technology transfer of manufacturing workflows to Contract Development and Manufacturing Organizations (CDMOs), helping ensure timely and reliable entrance to the clinic and eventual commercialization.

• Shift Requirements: Full-time, standard business hours, with on-site presence during scale-up/GMP manufacturing activities as needed
• Location: On-site laboratory setting
• Flexibility & travel: Minimal to no travel; on-site presence required to support lab operations, with occasional travel to CDMO sites for technology transfer

• Work at the bench to design and develop scalable, robust, and controlled GMP-ready processes for synthetic small molecules
• Collaborate with analytical groups within or outside the organization to establish supportive analytical characterization of synthetic intermediates and final products
• Discuss plans and data in multi-functional teams to evaluate processes and determine developmental goals, ensuring integrated program success
• Use statistical design of experiments (DOE) to optimize synthetic chemical processes, including reaction parameters, purification operations, and analytical characterization
• Partner with the External Manufacturing group and other key partners at Regeneron's IOPS organization to provide technical assessment of CDMOs intended for GMP production and successfully transfer processes with immediate, first-time success
• Research, identify, and develop new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT)
• Author robust technology transfer documentation and support production with onsite presence during scale-up/GMP manufacturing activities
• Analyze and present data in a clear and cohesive manner to a broad audience, facilitating data-driven decision-making
• Author, review, or provide domain expertise for publications, reports, tech transfer documents, regulatory support documents, and patents
• Coach and mentor junior team members of the organization as needed

• This is a hands-on, on-site laboratory role requiring bench work to design and develop synthetic small-molecule processes, along with proactive compliance with lab safety and environmental safety expectations set by Regeneron and regulatory bodies such as the FDA and DoT.
• Flexibility to multitask and work both independently and within cross-functional teams, along with occasional onsite presence during scale-up/GMP manufacturing activities, is required.

• Bachelor's degree with 4 years of relevant experience, or Master's degree with 0-3 years of relevant experience, in active pharmaceutical ingredient (API) process development
• Strong initiative and drive to complete challenging tasks and learn new technologies
• Strong fundamental understanding of process chemistry and technology transfer principles
• Excellent interpersonal, verbal, and written communication skills, with the ability to think critically and demonstrate problem-solving skills
• Well-versed with purification techniques such as crystallization, extraction, and chromatography

• Experience with small molecules in the bioconjugates space
• Hands-on experience with organic molecule synthesis and characterization tools such as mass spectrometry, NMR, IR spectroscopy, and HPLC
• Proven experience scaling up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility
• Experience handling highly potent compounds using appropriate containment and best-practice procedures
• Well-versed with ICH/regulatory guidelines and their impact on process development of synthetic molecules and bioconjugates
• Experience working with cross-functional CMC teams, and experience authoring publications, reports, tech transfer documents, regulatory support documents, and patents

• Student Loan Paydown program & Tuition Reimbursement
• Family Care Benefits
• Relocation Assistance
• Inclusion, Culture and Well-Being programs (including physical & mental health)

#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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)