Regeneron’s Bioanalytical Sciences group, located in Tarrytown NY, is seeking a passionate Sr Scientist . In this role you will function as a Principal Investigator responsible for clinical bioanalysis of PK, Immunogenicity and biomarkers within Bioanalytical Sciences and will serve as a liaison between bioanalytical team and clinical study teams to play a meaningful role in advancing clinical development.
A Typical Day in the Role Might Look Like:
Coordinate the sample analysis of pharmacokinetic, immunogenicity and biomarkers from clinical studies. Review bioanalytical data to ensure the quality and integrity of data.
Act as a liaison between Bioanalytical Sciences (BAS) and clinical development team, work closely with groups within BAS, Clinical Pharmacology group, clinical study teams and other working groups to establish bioanalytical deliverables and timelines for multiple projects. Ensure they are achieved to support clinical development.
Prepare and review sample analysis documentation and clinical sample analysis reports. Contributes to regulatory submissions and responses to regulatory inquiries.
Review clinical study related documents including study concepts, protocols, amendments, statistical analysis plan (SAP) and clinical study reports (CSR).
Review SOPs, publications, and guidelines to ensure the process for bioanalysis is aligned with industry practice and/or regulatory expectations.
Participate in internal and external project teams. Prepare and present scientific data at internal and external meetings
This Role Might Be For You If You:
You are a self-motivated, energetic individual
You enjoy working in a fast-paced, cross-functional setting
You thrive in a team-based, collaborative environment
This role requires PhD, MD or PharmD with 0-3 years of proven experience in the pharmaceutical or biotech industry. Experience with immunological techniques such as ELISA, ECL, MSD preferred. Knowledge and/or experience with biologics pharmacokinetics (PK) assays and immunogenicity assays and familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis highly preferred. Experience with writing/reviewing study reports and contributing to regulatory submissions with strong project management and interpersonal skills a plus. Knowledge in Oncology a plus.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$106,200.00 - $173,200.00