Regeneron Pharmaceuticals, Inc.
Tarrytown, New York, United States
Job type: fulltime
Job industry: Science & Technology
Our Bioanalytical Sciences Group is looking for a Scientist who will be Principal Investigator responsible for clinical bioanalysis of PK, Immunogenicity and biomarkers within Bioanalytical Sciences. You will serve as a liaison between bioanalytical team and clinical study teams to play a meaningful role in advancing clinical development.
A Typical Day Might Look Like This:
- Responsible for the overall conduct of bioanalysis 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, the 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 compliant with industry practice and/or regulatory expectations.
- Participate in internal and external project teams. Prepare and present scientific data at internal and external meetings
- You have strong initiative and aim to complete challenging tasks and learn new technologies.
- You are capable of multi-tasking, working both independently and within a team environment.
Minimum two (2) years of experience in the pharmaceutical or biotech industry, experience with a Contract Research Organization (CRO) preferred.Experience with immunoassay techniques such as ELISA, ECL and MSD, as well as LC-MS/MS. Knowledge and/or experience with pharmacokinetics (PK) assays and immunogenicity assays for biotherapeutics desired. Experience with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis.Familiarity with LIMS (Laboratory Information Management Systems) preferred. Writing/reviewing study reports and contributing to regulatory submissions exposure preferred. 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 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.