Project Specialist Quality Control
Regeneron Pharmaceuticals
Summary
We are currently looking to fill a Project Specialist on our Quality Control Technical Resources Team. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing.
Job description
When & Where
- Monday–Friday, 8:00am–4:30pm
- Location: Rensselaer, New York, United States
Discover your role
- Project manage validation and qualification activities within the QC TR Chemistry group
- Collaborate with internal and external teams to coordinate project management activities
- Write and revise assay transfer protocols to external partners and contract labs
- Write and revise control test procedures and SOPs
- Coordinate and participate in weekly project update meetings
- Communicate to management any delay in validation/transfer timelines
- Communicate method updates to partners and manage progress of updates
- Coordinate post-transfer investigations between contract sites and collaborative partners
- Raise discrepancies to management, as needed
- Multi-task, prioritize and execute projects independently
- Write and review transfer documents such as protocols and reports
- Communicate cross-functionally to business units
- Develop and drive scientific and/or business-related improvement ideas
- Possess effective time management skills, and the drive to meet deadlines
- Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
This role requires
A BS/BA in Chemistry, Biochemistry, Biology or related field, with 3+ years of relevant experience. Experience with project management and experience in a GMP setting. Level is determined based on qualifications relevant to the role.
Requirements
- BS/BA in Chemistry, Biochemistry, Biology or related field
- 3+ years of relevant experience
- Experience with project management
- Experience in a GMP setting
- Working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Benefits
- Health and wellness programs
- Fitness centers
- Stock awards
- Annual bonuses
- Incentive plans
- Pension or retirement benefits
- 401(k) company match
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.