Staff Scientist (Bioanalytical Operations)

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 Bioanalytical Lead responsible for the conduct and reporting of the clinical bioanalysis of PK, Immunogenicity and biomarkers within Bioanalytical Sciences and will serve as a liaison between bioanalytical team and clinical study teams. This individual will play a critical role in ensuring that the bioanalysis is performed in a compliant manner and that the reported results are accurate. This individual will work closely with the bioanalytical team, the clinical teams and regulatory personal to draft and review documents in order to advance clinical development.

Responsibilities

• Bioanalytical lead responsible to the overall conduct and reporting of bioanalytical studies. Works closely with the bioanalytical management and analytical teams to coordinate work, review data and transfer data sets to customers.
• Serves as a liaison between Bioanalytical Sciences (BAS) and clinical development team. Works closely with groups within BAS, Clinical Pharmacology, Clinical Study Teams, Regulatory, Program Management and Corporate Partners to establish bioanalytical deliverables and timelines for multiple projects. Ensure deliverables are met to support clinical development and corporate goals.
• Prepare, review and finalize bioanalytical data sets and reports. Contributes to regulatory submissions and responses to regulatory inquiries.
• Reviews clinical study related documents including study concepts, protocols, amendments, statistical analysis plan, clinical pharmacology reports and clinical study reports.
• Reviews SOPs, industry publications, and regulatory guidelines to ensure the process for bioanalysis is compliant with industry practice and/or regulatory expectations.
• Participates in internal and external project teams. Prepare and present scientific data at internal and external meetings. Stay current with all relevant industry and regulatory publications and guidance.

Requirements

• Ph.D. required with 2+ years of experience in the pharmaceutical or biotech industry
• Experience with immunological techniques such as ELISA, ECL, MSD
• Knowledge and/or experience with pharmacokinetics (PK) assays, biomarker assay and immunogenicity assays for Biologics.
• Familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis.
• Experience with writing and reviewing bioanalytical reports, clinical study reports, regulatory submissions and regulatory responses.
• 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 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.
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