Principal Scientist - Bioanalytical Sciences
Regeneron Pharmaceuticals
Summary
Regeneron's Bioanalytical Sciences group, located in Tarrytown, NY, is looking for a Principal Scientist. In this role you will serve as the Bioanalytical Sciences Lead to manage bioanalytical strategy and oversee bioanalytical activities for clinical programs. Acts as the liaison between Bioanalytical Sciences (BAS) and clinical study teams to effectively manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables and timelines for clinical studies. Supports regulatory submissions and interactions to ensure the completeness of sections related to immunogenicity and bioanalysis of PK and target biomarker samples.
Job description
Discover your role
- Serve as the Bioanalytical Sciences Lead on clinical study teams and participates on project teams both internal and external to Regeneron to oversee bioanalysis for clinical studies.
- Contributes to the development and management of bioanalytical strategy including immunogenicity risk assessment, assay selection, and sampling timepoints for clinical programs.
- Act as a liaison between Bioanalytical Sciences (BAS) and the clinical development team, work closely with groups within BAS, as well as the Clinical Pharmacology group, Regulatory Affairs, clinical study teams, and other working groups to establish bioanalytical deliverables and timelines for multiple projects.
- Review sample analysis documentation and clinical sample analysis reports.
- Contribute to regulatory submissions and responses to regulatory inquiries.
- Contribute to and review clinical study-related documents including expanded synopses, protocols, amendments, statistical analysis plan, and clinical study reports.
- Review data, SOPs, publications, and guidelines to ensure the conduct of bioanalysis is compliant with industry practice and/or regulatory expectations.
- Prepare and present scientific data at internal and external meetings.
This role requires
- PhD or BS/MS with 5+ years of experience in immunology, pharmaceutical sciences, or related field.
- Experience with bioanalytical techniques, e.g., ELISA, ECL (MSD), LC-MS, PCR, flow cytometry, or immunogenicity assays.
- Experience with writing/reviewing scientific documents, reports, and contributing to regulatory submissions.
- Strong communication, project management, and interpersonal skills.
Requirements
- PhD or BS/MS with 5+ years of experience in immunology, pharmaceutical sciences, or related field
- Experience with bioanalytical techniques, e.g., ELISA, ECL (MSD), LC-MS, PCR, flow cytometry, or immunogenicity assays
- Experience with writing/reviewing scientific documents, reports, and contributing to regulatory submissions
- Strong communication, project management, and interpersonal skills
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Life and disability insurance
- 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.