Regeneron's Nonclinical Bioanalysis (NBA) is seeking a highly motivated Scientist to add to its growing team. This individual will function as a Principal Investigator responsible for nonclinical bioanalysis of PK, Immunogenicity and biomarkers within NBA. They will serve as a liaison between NBA and other nonclinical study teams to play a meaningful role in preclinical development.
A Typical Day in this role may look like:
- The Scientist will lead all aspects of sample analysis of pharmacokinetic, immunogenicity and biomarkers from nonclinical studies. Review bioanalytical data to ensure the quality and integrity of data
- Prepare and review sample analysis documentation and nonclinical bioanalytical reports. Contributes to regulatory submissions and responses to regulatory inquiries.
- Review nonclinical study related documents including protocols and amendments
- 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 externals meetings.
This May Be For You If:
You have a PhD, MD or PharmD and a minimum of two (2) years of experience in the pharmaceutical or biotech industry.
- Experience with bioanalytical techniques such as ELISA, ECL, MSD, LC/MS, PCR-based methods
- Knowledge and /or experience with pharmacokinetics (PK) assays and immunogenicity assays
- Experience with outsourcing bioanalytical assays and oversight of CRO activities
- Familiar with bioanalytical regulatory guidance, including the GLPs, and industry standard practices for conducting nonclinical bioanalysis
- Experience with writing/reviewing bioanalytical reports and contributing to regulatory submissions
- Strong communication skills and enjoy working a cross-functional environment
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 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.