Manufacturing Quality Specialist

Artiva Biotherapeutics•San Diego, CA

3d•Onsite

About The Position

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 : The Manufacturing Quality Specialist will serve as the primary interface between Manufacturing (MG) and Quality, ensuring compliance, documentation accuracy, and continuous improvement across manufacturing operations. This role is responsible for quality event ownership, document control, training oversight, and data analysis to support CMC activities. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance , will be a self-starter , and can work independently to achieve corporate objectives . This is a full-time position reporting to the Associate Director of Manufacturing and is located at our corporate headquarters in San Diego, CA.

Requirements

Bachelor’s degree in relevant science or engineering discipline, or equivalent work experience.
Minimum 5 years of e xperience in cGMP biologics or cell culture manufacturing .
E xperience in biotech or cell therapy manufacturing is preferred .
Aseptic gowning and manufacturing in an ISO/Grade clean room environment.
Strong knowledge of GMP manufacturing and quality systems .
Excellent technical writing and documentation control skills .
Experience with quality investigations and root cause analysis .
Strong cross-functional communication and stakeholder management .
Data analysis and reporting skills .
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Willingness to think outside of the box and adapt best practices to our small, but growing environment.
Ability to adapt in a constantly evolving environment.
Self-motivated with a strong sense of ownership in areas of responsibility.
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

Nice To Haves

Experience in the following preferred:
Cell counting on various platforms .
Cell culture and expansion using bag systems , single use large scale bioreactors, and others where applicable.
Sartorius systems experience a plus.
Cell harvesting and washing processes , both automated and manual .
Cell selection and depletion techniques using Miltenyi CliniMACS Prodigy.
Fill finish and Cryopreservation processes and equipment.

Responsibilities

Serve as the primary liaison between Manufacturing (MG) and Quality, ensuring alignment on quality expectations, investigations, and resolutions .
Act as the primary author and owner of quality events, including , but not limited to D eviations , C orrective and Preventive Actions (CAPA) , Nonconformance Material Reports (NCMR) , and Change Controls .
Manage and execute document revisions and lifecycle management of Manufacturing documents , including Master Batch Records (MBR) , Equipment Procedures (EQT) , Standard Operating Procedures (SOP) , Standard Forms (SFM) , Work Instructions (WRK) , and Training Documents (TLT ) .
Maintain training and qualification tracking for manufacturing and cleaning contract personnel
Author and review APV reports and other manufacturing quality documentation
Execute and support Master Batch Record (MBR) and logbook review to ensure completeness, accuracy, and compliance .
Perform data tracking, analysis, and trending across CMC functions .
Support continuous improvement initiatives by identifying trends, risks, and opportunities for process and compliance enhancement .

Benefits

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.