Sr. Scientist, Analytical R&D

Overview

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.

The successful candidate will work independently, communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, author technical reports, advise junior scientists, and participate in cross-functional teams. They will enable and accelerate vaccine process development by applying cellular biology, virology, and immunology expertise.

• Design, execution, and interpretation of method development, optimization, and transfer of cell-based assays and immunoassays for vaccine development and characterization.
• Build and implement new assay platforms and benchmark current approaches against industry standards to reflect the mechanism of action (MoA) of vaccine candidates across the pipeline.
• Communicate results to stakeholders and present at external scientific meetings; author technical reports; advise junior scientists; participate in cross-functional teams.
• Contribute to vaccine process development through application of cellular biology, virology, and immunology expertise.
• Work independently in a GxP-regulated laboratory environment with attention to documentation and data integrity.

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.

Required Experience And Skills

• 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, imaging) for immunological and cell-based assay development.
• Experience working with mammalian cell lines and BSL-2 level biological agents.
• Strong team player with excellent oral and written communication skills; ability to work independently.
• Ability to deliver on complex objectives in a fast-paced, dynamic environment.

• Proficiency with data analysis and statistical software (e.g., JMP), curve-fitting software (e.g., PLA, Soft Max Pro, Graph Pad Prism), and data trending software (e.g., Spotfire).
• Experience with assay qualification/validation per ICH guidelines (range, accuracy, intermediate precision, repeatability).
• Experience applying innovative technologies to bioassay development (cell line engineering, stable clone generation, cell banking, cell imaging).
• Knowledge of DoE for potency assays and minimizing assay variability.
• Experience in regulated environments with SOPs, real-time documentation, and attention to detail.
• Experience with automation of assays.
• Working knowledge of regulatory and industry guidelines for Chemistry Manufacturing and Controls (CMC).

Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Biological Sciences, Biopharmaceutical Industry, Cell-Based Assays, Immunochemistry, Microbiology.

• Current Employees apply HERE;
  Current Contingent Workers apply HERE.
• US and Puerto Rico Residents Only; accommodations available on request during the hiring process.
• As an…