Requisition ID: PHA001474
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.
The Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) at West Point is seeking an experienced bioanalytical scientist to join the Regulated PK Bioanalytical group. The primary role of the position will be to develop, optimize, validate, and utilize ligand-binding assays (LBA) to measure drug levels in biological matrix to support pre-clinical GLP studies as well as clinical studies. The successful candidate will provide input in the design of experiments to develop and optimize PK assays, evaluate new techniques, validate and troubleshoot GLP assays, and test pre-clinical and clinical samples as needed.
Serve as a key member of the team responsible for developing ligand binding assays to monitor drug levels in biological fluids in support of Merck development programs.
Responsible for method development, validation, trouble-shooting, and/or pre-clinical/clinical sample analysis as needed.
Screen and characterize reagents to support PK LBA development.
Ensure GLP compliance. Support study protocol and assay validation report preparation. Address QA findings and observations.
Assess and implement new LBA technologies for PK assays.
Serve as an internal subject matter expert on developed assays, providing technical support, as needed to internal and external laboratories working to implement assays.
Education Minimum Requirement:
Bachelor's Degree in Immunology, Microbiology, Virology, Molecular Biology, Biochemistry or related discipline with at least 7 years of experience.
Master's Degree with at least 4 years of experience.
Ph.D in Immunology, Microbiology, Virology, Molecular Biology, Biochemistry or related discipline.
Required Experience and Skills:
Experience with development, optimization, validation and execution of ligand binding assays in a regulated bioanalytical environment.
Experience with Good Laboratory Practice (GLP) as it applies to regulated bioanalysis.
Experience in multiple immunoassay platforms such as MSD, Gyros, Luminex, ELISA, or AphaLISA is required.
Excellent written and verbal communication skills.
Ability to openly share information and work in a team setting.
Preferred Experience and Skills:
Experience in LC-MS based bioanalytical method development and sample testing is a plus.
Familiarity with liquid handlers and other automation platforms for sample preparation and assay process is preferred.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.