OFFICIAL JOB APPLICATIONS MUST BE SUBMITTED TO THE MERCK JOB SITE AT www.merck.com
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
We are seeking a highly motivated principal scientist to join the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) in the area of Regulated Immunogenicity/Molecular Biology Bioanalytics. The qualified candidate will be responsible for establishing our scientific strategy to influence general and program-specific immunogenicity (anti-drug antibody, ADA) assay development with a line of sight to successful biologics product approvals.
• Scientific leadership and oversight of the development and validation of new immunogenicity assays for GLP and clinical applications.
• Author regulatory filings and respond to regulatory authority questions pertaining to bioanalytical immunogenicity strategy and execution. The candidate will perform risk assessments, author reports, and interpret study data.
• Benchmarking current approaches/techniques to the industry standards.
• Design, pressure-test, and implement novel approaches, such as new technology, automation, and workflows.
• The candidate is expected to remain current in the field and maintain an external presence in the field of biologics immunogenicity.
Knowledge of preclinical and clinical testing in a regulated environment, and experience as a technical lead or scientific mentor is required. The candidate will be expected to communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams.
Education Minimum Requirement:
PhD in Biological Sciences such as Microbiology, Immunology, and Biochemistry, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience.
Internal Number: PHA001485
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