Senior Associate, Quality Control, Raw Materials

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 96,000 - 110,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Quality Control Associate to support raw materials testing and ensure compliance with regulatory standards. The role involves performing GMP testing, reviewing results, and managing documentation. Candidates should possess a BS or BA in a scientific field and have at least 4 years of experience in a cGMP environment. This position offers a competitive salary range of $96,000 - $110,000.

Qualifications

• Minimum 4 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting.
• Strong knowledge of regulatory expectations (USP, EP, ICH).
• Experience with cell therapy-relevant materials.

Responsibilities

• Perform GMP testing of raw materials including identity and sterility.
• Review and approve raw material test results.
• Support internal, external, and regulatory audits.

Skills

cGMP QC experience

Knowledge of raw material testing requirements

Technical writing skills

Critical thinking

Microsoft Office skills

Education

BS or BA in a relevant scientific field

Tools

LIMS

ELN

Job description

About Artiva

Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.

Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.

For more information, visit www.artivabio.com.

Job Summary

Artiva Biotherapeutics is seeking a skilled and motivated Senior Quality Control Associate who will be reporting to the Sr. Manager, Quality Control of Raw Materials. This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva’ products.

Duties/Responsibilities

• Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing
• Execute material qualification activities for new vendors, materials, and alternate suppliers
• Review and approve raw material test results and disposition materials in accordance with internal procedures
• Ensure timely testing and release to support manufacturing schedules
• Author, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controls
• Maintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systems
• Support internal, external, and regulatory audits (FDA, EMA, etc.)
• Act as a subject matter expert (SME) for raw material testing methods and regulatory expectations
• Troubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) results
• Lead or support method transfers, verifications, and validations for raw material assays
• Evaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreements
• Identify opportunities to improve testing efficiency, data integrity, and compliance
• Support implementation of new technologies, methods, and systems
• Participate in cross-functional teams with QA, Manufacturing, Materials Management and Product Development
• Coordinate sample shipments for contract testing labs for quality control.
• Support or lead QC special projects as needed

Qualifications

• BS or BA or a relevant scientific field, preferably biology or a related field.
• At least 4 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• Strong knowledge of raw material testing requirements and regulatory expectations (USP, EP, ICH)
• Experience with cell therapy-relevant materials (media, cytokines, sera, reagents, consumables)
• Experience with compendial and non-compendial methods

• Knowledge and experience in supporting cGMP deviations, OOS, etc.
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application

• Excellent critical thinking and technical writing skills.
• Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs

If all this speaks to you, come join us on our journey!

Base Salary: $96,000 - $110,000. Exact compensation may vary based on skills and experience.