Scientist / Staff Scientist (Bioanalytical Sciences)

Location
Tarrytown, New York, US
Posted
Jul 13, 2018
Ref
13405BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary
This individual 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 critical role in advancing clinical development.

Responsibilities
  • 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
  • Oversee the sample analysis of pharmacokinetic, immunogenicity and biomarkers from clinical studies. Review bioanalytical data to ensure the quality and integrity of data.
  • 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

Requirements
  • Experience with immunological techniques such as ELISA, ECL, MSD
  • Knowledge and/or experience with biologics pharmacokinetics (PK) assays and immunogenicity assays
  • Familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis.
  • Experience with writing/reviewing study reports and contributing to regulatory submissions
  • Strong project management and interpersonal skills
  • Knowledge in Oncology a plus

Minimum educational requirements :Ph.D./ PharmD/ MD

Minimum Years of Experience: 2+ years of experience in the pharmaceutical or biotech industry

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.