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San Diego, California, United States • On-site
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Lead the strategic direction of the cell potency analytical development team to optimize assays for NK cell-based therapies. This includes mentoring scientists, overseeing assay transfers to QC, and authoring regulatory submissions such as IND/BLA.
Requires a PhD in a relevant scientific discipline with over 10 years of industry experience in analytical development. Expertise in cell-based potency assays and experience in a regulated GXP environment are highly preferred.
About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com.
Job Summary:
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. This position will report directly to the Director, Analytical Development.
Duties/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
Requirements:
In addition to a great culture, we offer:
If all this speaks to you, come join us on our journey!
Base Salary: $ 170,000 - $185,000. Exact compensation may vary based on level, skills and experience.
We are dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit.
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
Offices: 5505 Morehouse Drive, Suite 100, San Diego, California 92121, US
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