Director Combination Product Development jobs in United States
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Regeneron · 1 week ago

Director Combination Product Development

Regeneron is seeking a Director of Combination Product Development to provide technical expertise and implement strategic visions for combination products. This role involves collaboration with internal teams and external partners to drive device and packaging development, ensuring alignment with therapeutic programs and supporting manufacturing processes.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Collaborate with Combination Products senior leadership to revamp and execute Regeneron’s combination product development strategies
Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants, ensuring alignment and project success
Provide technical expertise to guide the development of devices, packaging, and accessories for therapeutic programs
Interface with internal teams, alliance partners, and suppliers to ensure effective communication, alignment, and project execution
Oversee the creation and maintenance of thorough documentation, including Design History Files, quality engineering data, human factors and usability study results
Provide expertise and documentation for regulatory filings, ensuring compliance with device design, manufacturing process controls, and quality risk management standards
Support device component manufacturing and clinical/commercial manufacturing of combination products
Provide technical support for qualification activities, assembly guidance, process controls, and risk assessments for Regeneron’s internal fill-finish manufacturing operations

Qualification

Combination product developmentDevice manufacturingRegulatory complianceTechnical expertiseProject managementCollaborationCommunicationLeadership

Required

Bachelors degree in Science, Engineering, or related discipline
10+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience for Associate Director
12+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience for Director

Benefits

Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels

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