Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies (PMPD)

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Staff Engineer for its Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will provide scientific leadership and support for synthetic oligonucleotide process development using the principles of Quality by Design (QbD), process scale-up, and technology transfer of manufacturing-related workflows at Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic through product commercialization.

A typical day in the role of Staff Engineer might include:

• Designing and developing scalable, robust and controlled cGMP-ready processes for the chemical synthesis, purification, and isolation of oligonucleotides across early and late-stage process development.
• Ensuring a team-based evaluation of processes by working closely with several groups such as R&D Chemistry, Formulations Development, Analytical Chemistry, Protein Biochemistry, CDMOs, and other key stakeholders to ensure integrated program success.
• Generating robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities.
• Partnering with the External Manufacturing group and other key partners at Regeneron’s Industrial Operations and Product Supply (IOPS) organization to vet CDMOs and successfully transfer processes with immediate, first-time success.
• Promote new technologies for process improvements, predictive process models, and novel at-line/in-line process analytical technologies to ensure robust processing.
• Reviewing and providing domain expertise for regulatory submissions.
• Authoring publications, reports, tech transfer documents, regulatory support documents, patents.
• Scientifically up-to-date on advances in process chemistry and related disciplines
• Requires up to 20% travel

This role may be for you if you:

• Have strong initiative and aim to complete challenging tasks and learn new technologies.
• Are capable of multi-tasking, working both independently and within a team environment.
• Have excellent interpersonal, verbal and written communication skills.
• Can think critically and demonstrate problem-solving skills.

This role requires a Ph.D. or Master’s in organic chemistry or a related field. At least 5 years of industrial experience post-PhD or at least 7 years of experience post-Masters in active pharmaceutical ingredient (API) process development is preferred. Experience with small-molecules in the bioconjugates space will be highly preferable. Hands-on experience with solid-phase oligonucleotide synthesis, purification, and characterization using techniques such as mass spectrometry (MS), nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, and high-performance liquid chromatography (HPLC) is preferred. Proven experience in scaling-up synthetic oligonucleotide syntheses and technology transfer to a GMP manufacturing facility 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 multi-functional Chemistry, Manufacturing and Control (CMC) teams and experience in authoring publications, reports, technical transfer documents, regulatory support documents, patents is a plus.