Scientist (External CRO Management)
Regeneron Pharmaceuticals
Summary
A Scientist within the Bioanalytical Outsourcing will be responsible for overseeing all bioanalysis (nonclinical and clinical) at external CROs. They will be responsible for coordination of assay development/qualification/validation efforts on various analytical platforms as well as the subsequent sample analysis and reporting efforts for each drug program. They will be responsible for communicating progress on these deliverables to the appropriate nonclinical and clinical colleagues and project teams. The successful candidate will have demonstrated technical proficiency, solid understanding of the GLPs, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment.
Job description
Discover your role
- Provide scientific and operational oversight on all aspects of bioanalytical activities conducted at Contract Research Organizations (CROs), independently and in collaboration with representatives of the Bioanalytical Outsourcing Team.
- Provide scientific support to CRO efforts in design, development, and implementation of a variety of analytical methods in a regulated (GLP, GCLP) environment and ensure that these activities are in line with current regulatory guidelines.
- Work with internal and external SMEs (Subject Matter Experts) to address any/all issues that may occur during assay development and/or sample analysis.
- Interface with CROs to ensure on time delivery of required milestones and proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders etc.
- Provide CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate.
- Facilitate with the review of GLP and GCLP compliance status at CROs.
This role requires
- A BS/MS with 10+ years experience in an industry setting.
- Hands-on experience with regulated bioanalysis.
- Hands-on experience with assay validation/qualification relevant under multiple platforms: LBA, LC/MS, PCR-based methods.
- Excellent documentation skills with attention to detail and overall data quality.
- Ability to clearly and concisely communicate project goals, deliverables internally and externally.
- Ability to multi-task and work under tight timelines.
- Preferred: Previous experience managing external CROs, coordinating bioanalysis, assay validation etc.
- Preferred: Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs etc).
Requirements
- BS/MS with 10+ years experience in an industry setting
- Hands-on experience with regulated bioanalysis
- Hands-on experience with assay validation/qualification under multiple platforms: LBA, LC/MS, PCR-based methods
- Excellent documentation skills with attention to detail and overall data quality
- Ability to clearly and concisely communicate project goals, deliverables internally and externally
- Ability to multi-task and work under tight timelines
- Preferred: Previous experience managing external CROs, coordinating bioanalysis, assay validation etc.
- Preferred: Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs etc).
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- 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.