Regeneron · 1 month ago
Sr Scientist, Formulations (Drug Product Development)
Regeneron is seeking a highly skilled and motivated Sr. Scientist to join Formulation Development's Drug Product Group. This role involves leading formulation studies and collaborating cross-functionally to advance drug product development initiatives for biologics.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Lead design and execution of high-throughput (HT) formulation studies to rapidly screen excipients for desirable physicochemical characteristics and stability for mAbs, peptides and fusion proteins etc. Perform HT analytical characterization and leverage statistical tools (e.g., JMP) to process large data sets efficiently
Support and lead process development, scale-up, technology transfer, and troubleshooting activities with Contract Manufacturing Organizations (CMOs) in collaboration with Industrial Operation & Process Sciences (IOPS)
Lead development and optimization of lyophilization cycles for various modalities across different phases of development
Perform biophysical and biochemical characterization of liquid and lyophilized formulations using techniques such as DSC, FDM, TGA, SE-UPLC, and others
Collaborate cross-functionally with colleagues from Product, Analytical & Preclinical Development (PAPD) and IOPS organizations to advance the program needs
Participate and contribute in cross-functional meetings to provide technical expertise and contribute to project planning and decision-making. Communicate effectively with stakeholders to ensure timely delivery of project milestones and objectives
Draft and review protocols, technical reports, and supporting documents towards regulatory filings
Stay abreast of advancements in DP Development technologies including novel process tools, HT methodologies, analytical tools and industry trends to drive innovation within the group
Identify and implement process improvements to enhance efficiency, scalability, and quality in lyophilization and formulation development
Qualification
Required
Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related field with 0 - 3 years of relevant industry experience; OR M.S. with 10+ years of experience
Strong problem-solving skills and ability to address technical challenges in a fast-paced environment
Ability to work independently and in team settings to drive the challenging task efficiently
Excellent technical writing, communication, and project management skills
Demonstrated ability to collaborate cross-functionally
Expertise in lyophilization process development, including design, execution, and troubleshooting
Preferred
Experience working with monoclonal antibodies and peptides is highly desirable
Hands-on experience with biochemical and biophysical techniques for protein characterization using chromatography (SE-UPLC, IEX, RP-UPLC), electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), UV-Vis, Viscosity and thermostability characterization (DSC, DSF)
Experience with statistical software (e.g., JMP) for design of experiments and data analysis preferred
Ability to build efficient workflows for formulation screening and analytical testing
Experience with automation tools is a plus
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
2026-01-08
2026-01-07
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