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

About the role

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.

Responsibilities

• 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

Requirements

• 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

Preferred Qualifications

• 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

Benefits

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

Pay

Salary Range (annually) $80,300.00 - $131,100.00

Schedule

Full-time, standard business hours, with on-site presence during scale-up/GMP manufacturing activities as needed

Minimal to no travel; on-site presence required to support lab operations, with occasional travel to CDMO sites for technology transfer