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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
We are looking for PhD Scientist /Staff Scientist in the Bioanalytical Operations group that would function as Principal Investigator responsible for PK, Immunogenicity and biomarker analysis of clinical studies within Bioanalytical Operations
- Manage multiple projects within Bioanalytical Operations (BAO). Work closely with groups within BAO, clinical teams and other working groups to establish project objectives and ensure they are achieved to support clinical development
- Oversee the bioanalysis of pharrnacokinetic, immunogenicity and biomarker samples from clinical studies and ensure quality of data and regulatory compliance
- Prepare and review clinical sample analysis reports, contributions to regulatory submissions and responses to regulatory inquiries
- Contribute to and review study protocols, SOPs, publications, and guidelines
- Participate in internal and external project teams as a department liaison. Prepare and present scientific data at internal and external meetings
- This position requires a PhD and 5+ years of experience in the pharmaceutical or biotech industry
- Experience with immunological techniques such as ELISA, ECL, MSD
- Knowledge and/or experience with biologics pharmacokinetics (PK) assays and immunogenicity assays
- Understanding of bioanalytical regulatory guidances and industry standard practice
- Experience with writing/reviewing study reports and contributing to regulatory submissions
- Strong project management and interpersonal skills
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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
To apply for this position, please CLICK HERE