Title: Principal Scientist
Department: Analytical Development
Reports To: Sr. Director Analytical Development
The Principal Scientist will be responsible for developing and managing analytical method development, validation, release and stability specification assays, and additional assays needed to support cell and gene therapy client programs for The Discovery Labs. The candidate will advance strategic and scientific direction for the department to establish analytical development, analytical method lifecycle management strategies, and implement novel technologies. The candidate should also understand the regulatory requirements around these activities and have experience in team leadership as well as knowledge and skills in analytical development.
● Direct technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs.
● Advance scientific understanding of cell therapy products by applying state-of-the-art cellular analytics research techniques and leading studies that aim to deepen product understanding.
● Serve as a technical interface between analytical development, testing and process development departments to ensure efficient and rapid method transfer/qualification execution.
● Provide scientific and technical guidance and serve as SME for flow cytometry, molecular, virology and cellular analytical capabilities.
● Support CMC and product development teams to ensure robust data analysis, solid GMP method implementation, and broad incorporation of analytical strategy within CMC functions.
● Balance resource allocation based on project priorities. Communicate effectively to staff and key partners and stakeholders.
● Oversee the design, development, and qualification of analytical methods to assess product identity, purity, quality and potency. Collaborate with other Analytical Development (AD) departments to ensure the overall analytical strategy is complete and phase appropriate as a member of the AD leadership team.
● Coordinate, lead and participate in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, Testing, Process Development, Clinical and Commercial Manufacturing, and Quality teams.
● Provide scientific guidance to development operations, and clinical and commercial QC teams. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and products.
Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.
● Represents Testing on Client Product Teams and supports client meetings, design of testing programs and is the primary contact for the Client Analytical Development counterpart.
Education & Experience
● PhD in cell biology, Immunology, molecular Biology, or related discipline with 10 years R&D/analytical development experience or MS with years of experience.
● Previous industry or academic experience in cell and gene therapy, CAR-T research and development is preferred.
● Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus.
● Extensive technical experience in flow cytometry, molecular biology, virology and/or cell-based potency methodologies
● Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management
● Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
● Strategic thinker with excellent problem solving and conflict resolution skills.
● Ability to foster a strong team-first environment with the ability to lead multiple projects.
● Demonstrated success in leading high performing assay development teams.