Principal Scientist, Analytical Development

artivabio; San Diego (CA); On-site; USD 170,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off (PTO)

Company holidays

Job summary

Artiva is seeking a senior leader to head the cell potency analytical development team in San Diego. You will define strategy, oversee assay development and validation, and collaborate with R&D and Process Development to advance NK cell therapies.

You will mentor scientists, author regulatory sections, and oversee method transfers to QC. This role requires a Ph.D. with 10+ years in analytical development in pharma/biotech, with NK, CAR-T experience preferred.

Qualifications

• Ph.D. in a relevant scientific discipline with 10+ years of industry experience in analytical development.
• Expertise in cell-based potency assays; NK/CAR-T experience desirable.
• Experience with assay validation is highly preferred.
• Experience with analytical techniques such as cell-based potency assays, flow cytometry, ELISA/MSD, and qPCR/ddPCR.
• Strong communication and leadership, ability to manage multiple projects.

Responsibilities

• Lead and set the scientific strategy for the cell potency analytics group, directing assay development and validation.
• Represent the function on cross-functional teams and governance bodies.
• Mentor scientists and analysts, ensuring high-quality data and documentation.
• Draft SOPs, reports, and regulatory submissions related to analytical methods.
• Oversee assay transfers to QC teams and external partners.

Skills

Cell potency

Leadership

Strategic planning

Project management

Communication

Cross-functional collaboration

Education

Ph.D. in Immunology, Microbiology, Cell or Molecular Biology or Biochemistry

Tools

Flow cytometry

ELISA/MSD

qPCR/ddPCR

Job description

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

• 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.

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:

• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

Base Salary: $ 170,000 - $185,000. Exact compensation may vary based on level, skills and experience.