Principal Scientist - Bioanalytical
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 assay development scientist to join the Regulated Bioanalytical group. The primary role of the successful candidate will be to provide scientific expertise and assay development for novel DNA/RNA therapeutics and vaccines. In addition, the successful individual should be able to provide strong scientific strategy into novel assay methodologies and platforms using state of the art technologies suitable for Regulated work.
The successful candidate will be a scientific leader, with a passion for developing assays, delivering high quality data, and helping teams choose the right assays for data-driven decision making. A record of accomplishment of successful collaboration while working in cross-functional project teams is expected. The successful candidate will also have responsibility for mentoring, scientific supervision, and training scientists, as well as contributing to setting Regulated Bioanalytical strategy.
- A Bachelor's Degree in Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, or a related area degree with a minimum of 14 years of relevant experience, OR a Master's Degree in Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, or related area with a minimum of 10+years of experience, OR a Ph.D. in Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, or a related area with a minimum of 8 years of experience.
- A minimum of 10 years of experience in PCR assay development and optimization including expertise in troubleshooting experimental design, assay development and data analysis.
- Strong technical expertise in regulated bioanalytical assay design, development and execution in support of antiviral, antibacterial, and/or vaccine discovery.
- Advanced knowledge in molecular biology assays such as DNA gel electrophoresis, DNA and RNA isolation, Real-Time PCR, reverse transcriptase PCR, and sequencing with demonstrated ability to achieve results.
- Ability to understand and implement applicable regulations regarding the use of pathogens (e. g. virus, bacteria, fungi), human cell and tissue use, laboratory safety, health physics and chemical hazards in research.
- Proven ability to lead the development of new, innovative approaches including experience with new assay technology evaluation and shaping scientific strategy both at the platform and program level.
- Excellent communication, mentoring, influencing and leadership skills. Ability to share knowledge and mentor more junior-level scientists
- Established external scientific reputation (e.g. publication record, leadership in consortia, external presentations).
- Expertise in authoring and reviewing program development documents and regulatory submissions as well as experience interacting with Health Authorities.
- In-depth understanding of the development process and comprehensive knowledge of the principles and concepts of vaccine clinical testing.
- Candidate must be trained in GLP requirements and must have experience working in a regulated laboratory environment generating data suitable for submission to regulatory agencies.
- Experience with immunoassay platforms such as MSD, Luminex, ELISA, AphaLISA is a plus.
- Experience in cell-based functional assays to monitor immunogenicity
- Familiar with liquid handlers and other automation platforms for sample preparation and assay process.
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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