Staff Scientist

Our Bioanalytical team at Regeneron is seeking an individual who will function as a Staff Scientist and Principal Investigator (PI) responsible for clinical bioanalysis to support assessment of PK, Immunogenicity and biomarkers within Bioanalytical Sciences. In this critical role in clinical development of biotherapeutics, you can serve as a liaison between bioanalytical team and the clinical study teams.

A Typical Day Might Look Like:

• Oversee the sample analysis of pharmacokinetic, immunogenicity and biomarkers from clinical studies. Independently review and approve raw data to ensure the quality and integrity of data
• Participate in internal and external project teams. Prepare and present scientific data at internal and external meetings
• Prepare and review sample analysis plan, clinical sample bioanalytical reports and related documentation
• Review SOPs, publications, and guidelines to ensure the process for bioanalysis is compliant with industry practice and/or regulatory expectations
• Work closely with inter and intra departmental cross-functional groups within BAS and inter departmental groups like Clinical Pharmacology, clinical study teams and other operational team meetings
• Review clinical study related documents including study concepts, protocols, amendments, statistical analysis plan (SAP) and clinical study reports (CSR)

This Job Might Be For You If:

• 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 position requires a PhD in Immunology, Pharmaceutical Sciences or a related field with a minimum 3 (3) years of demonstrated experience in either a Clinical Research Organization (CRO) pharmaceutical or biotech industry. Strong experience with immunological techniques such as ELISA, ECL, MSD, with experience in LCMS/MS preferred, with knowledge and/or experience regarding pharmacokinetics (PK) and immunogenicity of biologics a plus. Familiarity with the bioanalytical regulatory framework and industry standard practice for conducting clinical bioanalysis is required. Experience with writing/reviewing study reports and contributing to regulatory submissions is a plus. Experience in word processing, database, spreadsheet is required with skills in Watson, Nautilus-LIMS, and statistical software preferred. Strong project management with good interpersonal skills and knowledge of various Therapeutic areas is 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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.