Principal Scientist, Analytical Development

Artiva Biotherapeutics•San Diego, CA

1d•Onsite

About The Position

The incumbent will lead and set the strategic direction for the cell potency analytical development team to develop and optimize cell-based assays to support the characterization and release of our allogeneic, natural killer (NK) cell-based therapies. In this role, the incumbent will serve as the scientific subject matter expert for cell potency, defining the assay development strategy and directing the evaluation and development of new cell potency assay methods and product characterization for NK cell products. This role includes leading and mentoring a team of scientists and analysts within the cell potency group, providing scientific oversight of benchtop assay development, detailed documentation of methods and materials, authoring and reviewing SOPs/reports and communicating findings to the wider organization. This role will collaborate closely with R&D and Process Development teams to identify product attributes that advance optimal product development and assess function. They will also oversee/participate in assay optimizations, standardizations, and transfers to QC labs.

Requirements

Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Microbiology, Cell or Molecular Biology or Biochemistry) with 10+ years of industry experience in analytical development or equivalent demonstrable experience with analytical techniques.
Expertise in cell -based potency assay development; experience with NK and or CAR-T cells is highly desirable
Experience with assay validation highly preferred
In-depth experience in analytical techniques such as cell-based potency assays, flow cytometry, ELISA/MSD, and qPCR/ddPCR.
Excellent interpersonal, verbal, and written communication skills are essential.
Able to manage personnel and multiple projects in parallel, including key participation on multi-disciplinary project teams.
Demonstrated scientific leadership, including setting technical strategy, mentoring scientists, and influencing decisions across multidisciplinary teams.
Experience authoring analytical/CMC sections of regulatory submissions (e.g., IND/BLA) is preferred.
Attention to safety, good laboratory practice, and good documentation practice.
Experience in analytical development and testing in a Pharma/Biotech, regulated (GXP) environment is strongly preferred.
Experience in cell therapy, immunology, or oncology is preferred.
Experience with statistical programming or software (e.g., JMP) is a plus.

Nice To Haves

Experience with NK and or CAR-T cells is highly desirable
Experience with assay validation highly preferred
Experience authoring analytical/CMC sections of regulatory submissions (e.g., IND/BLA) is preferred.
Experience in analytical development and testing in a Pharma/Biotech, regulated (GXP) environment is strongly preferred.
Experience in cell therapy, immunology, or oncology is preferred.
Experience with statistical programming or software (e.g., JMP) is a plus.

Responsibilities

Lead and set the scientific strategy for the cell potency analytical development group, directing experimental design and execution to enable assay development, optimization, and characterization studies that enhance process and product understanding
Serve as the scientific subject matter expert for cell potency, setting long-term assay strategy and representing the function on cross-functional and project governance teams
Design and execute assay qualification and validation studies
Research and compare novel platforms to provide more optimal methods of characterizing in-process and final drug product
Lead, mentor, and develop scientists and analysts within the cell potency group, fostering their technical and professional growth
Develop assays to support process development, Clinical product release and stability, and product characterization needs.
Provide scientific and technical guidance to junior staff in the design and execution of laboratory experiments to generate high-quality data
Draft technical reports, standard operating procedures, and test protocols in support of analytical test method development
Author and review potency-related sections of regulatory submissions (e.g., IND/BLA) and support responses to health authority queries
Manage assay transfer to the Artiva QC team and external partners where applicable
Present data to cross functional team meetings to discuss findings and next steps