Associate Principal Scientist, Bioassay Development
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 associate principal scientist to join our Biologics Analytical Sciences team within Biologics BioProcess organization at Merck-Kenilworth. The qualified candidate will be responsible for development of fit-for-purpose surface plasmon resonance (SPR) and automated potency assays in the assessment of biological activity and characterization for various early and late-stage biologics such as antibodies, bispecifics, multifunctional proteins, and antibody drug conjugates; other reponsibilities include development of new assay platforms and benchmarking current approaches/techniques to the industry standards. 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 in cross-functional teams.
- A degree in biochemical and biological sciences/engineering: Ph.D. degree with 4+ years or M.S. degree with 12+ years of professional drug development experience in the pharmaceutical industry.
- Expertise in SPR/Biacore assay development, troubleshooting, and data analylsis/review/interpretation of protein-ligand interactions.
- Expertise in automated liquid handling devices such as instruments made by Biomek, Tecan, Hamilton, etc.
- Expertise in developing potency-based immunoassays for biotherapeutic drug candidates.
- Experience in applying a variety of biochemical, biological, and immunological techniques (ELISA, cell-based assays, FACS, MSD, EnVision, ForteBio, etc.).
- Experience with QbD and statistical analysis (DoE, JMP, Design Expert, etc.).
- Experience in various aspects of drug development (pre-clinical,early, and late stage) and lifecycle support, and ability to develop useful strategies and tactics to meet regulatory milestones.
- A strong team player with excellent oral and written communication skills; ability to work independently to develop and design experiments, critically evaluate data, and troubleshoot.
- Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
- Working knowledge of biological assay qualification, validation, and transfer to an cGMP environment.
- Experience in bioassay development for modalities such as bispecifics and multifunctional proteins is highly desired.
- Experience in effectively managing analytical development and testing activity at external vendors such as CROs.
- Working knowledge of regulatory and industry guidelines in the area of bioassay development.
- Experience in authoring of regulatory submissions.
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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Job: Biologics, Vaccines, Analytical Formulat
Employee Status: Regular
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Company Trade Name: Merck