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.
When & where:
- Location: Tarrytown, NY
- Work model/flexibility: 4 days onsite
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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
Salary Range (annually)
$128,600.00 - $210,000.00
