Sr. Scientist, Analytical R&D

MSD•Upper Gwynedd Township, PA

1d•$117,000 - $184,200•Hybrid

About The Position

The Analytical Research and Development team in West Point, PA is seeking an exceptional scientist who is passionate about innovative science and analytical solutions that enable and accelerate process and product development. The Senior Scientist within the department of Cell Based Sciences will join our vaccines team in West Point, PA. The Senior Scientist will play a key role with the primary focus on the design, execution, and interpretation of method development, optimization, and transfer of cell-based assays and immunoassays for drug substance and drug product release, stability studies, and in-depth product characterization to support our vaccine pipeline. Responsibilities include building and implementing new assay platforms and benchmarking current approaches and techniques to the industry standards. These assays are expected to robustly reflect the mechanism of action (MoA) of vaccine candidates across the pipeline. The successful candidate will be expected to work independently, communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to author technical reports, to advise junior scientists, and to participate in cross-functional teams. The individual will enable and accelerate vaccine process development by applying cellular biology, virology, and immunology expertise. The ideal candidate should have a deep understanding of relevant biological mechanisms and assay principles, and extensive experience with a broad range of methods and technologies used to access vaccine MoA and potency, with particular emphasis on cell-based assay and immunoassay development. Experience working in a GxP regulated laboratory environment (routine sample testing, documentation, and data verification) and experience with cell line engineering are highly desirable. Position Qualifications: Education Minimum Requirements: B.S degree with 6+ years of experience, M.S. degree with 4+ years of experience or Ph.D. degree in immunology, cell biology, bioengineering, biological sciences, biochemistry, virology, microbiology, or related field with experience in the biopharmaceutical industry.

Requirements

Demonstrated experience in cell-based bioassay development for vaccines, with a deep understanding of mechanisms of action and assay principles.
Scientific and technical expertise in cellular immunology and humoral / cell-mediated responses to vaccines.
Hands-on experience with a range of biological, immunological, and biochemical techniques (e.g., cell-based assays, reporter gene assays, ELISA, flow cytometry-based assays, qPCR, or imaging, etc.) for immunological and cell-based assay development.
Experience working with mammalian cell lines and BSL2 level biological agents.
A strong team player with excellent oral and written communication skills; ability to work independently.
Strong ability to deliver on complex objectives in a fast-paced, dynamic environment.
B.S degree with 6+ years of experience, M.S. degree with 4+ years of experience or Ph.D. degree in immunology, cell biology, bioengineering, biological sciences, biochemistry, virology, microbiology, or related field with experience in the biopharmaceutical industry.

Nice To Haves

Proficiency with data analysis and statistical software such as JMP, curve-fitting software such as PLA, SoftMax Pro, or GraphPad Prism, and data trending software such as Spotfire.
Experience with assay qualification/validation, including establishing range, accuracy, intermediate precision, and repeatability according to ICH guidelines.
Prior experience in bringing and applying innovative technologies suitable for bioassay development such as cell line engineering, stable clone generation, cell banking, and cell imaging.
Working knowledge of statistical approaches such as design of experiments (DoE) in developing potency assays to identify sources of assay variability, developing operating ranges within an assay procedure that keep assay variability at a minimum.
Experience working in a regulated environment, following standard operating procedures (SOPs), real-time documentation of experimental work, and attention to detail.
Experience with automation of assays
Working knowledge of regulatory and industry guidelines for Chemistry Manufacturing and Controls (CMC).

Responsibilities

design, execution, and interpretation of method development, optimization, and transfer of cell-based assays and immunoassays for drug substance and drug product release, stability studies, and in-depth product characterization to support our vaccine pipeline
building and implementing new assay platforms and benchmarking current approaches and techniques to the industry standards
work independently, communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to author technical reports, to advise junior scientists, and to participate in cross-functional teams
enable and accelerate vaccine process development by applying cellular biology, virology, and immunology expertise