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 team. The qualified candidate will be responsible for leading a scientific team to develop, optimize, qualify, validate, and transfer regulated cell based immunogenicity assays for GLP pre-clinical (GLP and clinical sample testing of vaccine and biologics products. Responsibilities include but are not limited to benchmarking current approaches/techniques to the industry standards, development of new cell assay platforms, and development of robust assays supporting the pipeline. The candidate will be responsible for establishing a scientific strategy to influence general and program-specific cell based assay development with a line of site to successful biologics and vaccines product approvals. Experience in regulated bioanalytical and scientific mentorship is highly desirable. The candidate is expected to have excellent oral and written communication skills to interface with internal and external teams, participate in external scientific meetings, to author submission documents, and to participate on cross-functional teams. The position will report to an Executive Director and be an active contributor to the Regulated Immunogenicity leadership team.
Required Experience and Skills:
- A Ph.D. degree in Chemistry, Biochemistry, Biological Sciences such as Microbiology, Immunology, Pharmaceutical Sciences, or related area with 8+ years, MD/PhD or DVM/PhD (Dual Degree), MS degree with 10+ years, or BS degree with 14+ years of relevant experience.
- Experience in regulated/clinical cell-based virus and/or biologics neutralization assays, ADA, opsonophagocytic assays, ELISPOT, flow cytometry, and intracellular cytokine staining.
- Experience with qualification, validation, and transfer of assays to a GLP or clinical laboratories.
- Proven ability to develop independently cell-based assays using modern technologies
- Scientific supervision of associate bench scientists
- A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays.
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
Preferred Experience and Skills:
- Ability to implement regulatory and industry guidelines in the area of vaccine clinical assay testing or biologics immunogenicity anti-drug antibody testing.
- Expertise in vaccine biology and/or cellular immunology is highly desired.
- Proficiency to utilize statistical software for design of experiments.
- Excellent scientific publishing records
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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