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About the Role
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.
Responsibilities
- 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.
- Contribute 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.
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.
Skills
- Bioanalytical strategy
- Pharmacokinetics (PK)
- Immunogenicity
- Biomarker deliverables
- Regulatory submissions
- ELISA
- ECL (MSD)
- LC-MS
- PCR
- Flow cytometry
- Immunogenicity assays
- Scientific document writing
- Scientific report writing
- Communication skills
- Project management skills
- Interpersonal skills
Location
- Tarrytown, NY
Work Type
- 4 days onsite
Experience Level
- Principal Scientist
Education Level
- PhD
- BS/MS
Salary/Compensations
- $128,600.00 - $210,000.00
Benefits
- 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
- Family support benefits
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron believes we do our best work when we are together.
- Many roles are required to be performed on‑site.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.