Principal Scientist - Bioanalytical Sciences

Regeneron Pharmaceuticals•Tarrytown, GA

2d•$128,600 - $210,000•Onsite

About The Position

Regeneron's Bioanalytical Sciences group in Tarrytown, NY is seeking a Principal Scientist to serve as the Bioanalytical Sciences Lead for clinical programs. The role manages bioanalytical strategy and oversees bioanalytical activities for clinical studies, serving as a liaison between Bioanalytical Sciences (BAS) and clinical study teams to manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables and timelines. The position also supports regulatory submissions and interactions to ensure completeness of sections related to immunogenicity and the bioanalysis of PK and target biomarker samples. The role works with internal and external project teams and coordinates with groups including BAS, Clinical Pharmacology, Regulatory Affairs, and clinical study teams. It contributes to bioanalytical strategy, reviews clinical sample analysis documentation and reports, and supports study documentation and regulatory responses. The work model is four days onsite in Tarrytown, NY.

Requirements

PhD, or BS/MS with 5 or more years of experience, in immunology, pharmaceutical sciences, or a related field.
Experience with bioanalytical techniques such as ELISA, ECL (MSD), LC-MS, PCR, flow cytometry, or immunogenicity assays.
Experience writing and reviewing scientific documents and reports, and contributing to regulatory submissions.
Strong communication, project management, and interpersonal skills.

Responsibilities

Serve as the Bioanalytical Sciences Lead on clinical study teams and participate on internal and external project teams 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 BAS and the clinical development team, working with BAS, Clinical Pharmacology, Regulatory Affairs, clinical study teams, and other working groups to establish bioanalytical deliverables and timelines across 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 plans, and clinical study reports.
Review data, SOPs, publications, and guidelines to ensure bioanalysis is conducted in compliance with industry practice and/or regulatory expectations.
Prepare and present scientific data at internal and external meetings.