Scientist - Formulation Process Development jobs in United States
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Regeneron · 1 month ago

Scientist - Formulation Process Development

Regeneron Pharmaceuticals is a leading biotechnology company focused on drug development and manufacturing. They are seeking a Scientist to support drug product process development studies for biologics and ensure robust process development and technology transfer to manufacturing sites.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Perform gap and risk assessment for drug product (e.g. manufacturing process, scale, contact parts, etc.) to inform requisite process development studies
Plan, design, and execute drug product process development studies for various biologics to ensure robust characterization of different unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.) across a number of fill sites
Assist in developing small-scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams
Support in-house drug product toxicological lot manufacturing campaigns as needed
Work closely with FDG leads/scientists to ensure seamless progression of multiple late-stage process-related activities
Prepare, review, and edit technical reports
Bring in new ideas from literature and present work at group, department, and cross-functional meetings with a goal to improve efficiencies (e.g. in-silico modeling approaches, process analytics and related tools)
Demonstrate strong and proactive problem-solving skills via critical thinking and effective communication
Manage process development equipment installation, operation, maintenance, calibration, and repairs

Qualification

Drug product developmentAnalytical instrumentsHPLC techniquesLyophilizationStatistical software (JMP)BiophysicsProblem-solvingCommunicationTeamworkCritical thinking

Required

BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with at least 10+ years of relevant industry experience or a MS degree with 8+ years of relevant industry experience
Experience with drug product development and characterization (formulation and process) required
Hands-on experience with analytical instruments used for biologics including HPLC-based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV-Vis), particle characterization methods (MFI and HIAC) required
Basic understanding of common protein degradation pathways and biophysics required
Demonstrate strong and proactive problem-solving skills via critical thinking and effective communication

Preferred

Experience with lyophilization is desired
Other quantification methods (ddPCR, ELLA, mass photometry) preferred
Experience with statistical software (JMP) to perform design of experiments and statistical analyses preferred

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

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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 Company
Total Funding
$15.93M
Key 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

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase