Regeneron · 4 days ago
Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies (PMPD)
Regeneron Pharmaceuticals is seeking a hardworking and dynamic Staff Engineer for its Synthetic and Bioconjugation Scale-up Technologies group. The role involves providing scientific leadership in synthetic oligonucleotide process development and ensuring successful technology transfer for manufacturing-related workflows at Contract Development and Manufacturing Organizations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
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
Qualification
Required
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
Strong initiative and aim to complete challenging tasks and learn new technologies
Capable of multi-tasking, working both independently and within a team environment
Excellent interpersonal, verbal and written communication skills
Ability to think critically and demonstrate problem-solving skills
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)
Proven experience in scaling-up synthetic oligonucleotide syntheses and technology transfer to a GMP manufacturing facility
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
Experience in authoring publications, reports, technical transfer documents, regulatory support documents, patents
Preferred
Experience with small-molecules in the bioconjugates space
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Recent News
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