Senior Associate, Quality Control, Raw Materials
Artiva Biotherapeutics
San Diego, CA
Analyst, Science / R&D / Research, Information Technology
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 testingExecute material qualification activities for new vendors, materials, and alternate suppliersReview and approve raw material test results and disposition materials in accordance with internal proceduresEnsure timely testing and release to support manufacturing schedulesAuthor, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controlsMaintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systemsSupport internal, external, and regulatory audits (FDA, EMA, etc.)Act as a subject matter expert (SME) for raw material testing methods and regulatory expectationsTroubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) resultsLead or support method transfers, verifications, and validations for raw material assaysEvaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreementsIdentify opportunities to improve testing efficiency, data integrity, and complianceSupport implementation of new technologies, methods, and systemsParticipate in cross-functional teams with QA, Manufacturing, Materials Management and Product DevelopmentCoordinate 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 methodsKnowledge 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 applicationExcellent 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.
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 testingExecute material qualification activities for new vendors, materials, and alternate suppliersReview and approve raw material test results and disposition materials in accordance with internal proceduresEnsure timely testing and release to support manufacturing schedulesAuthor, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controlsMaintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systemsSupport internal, external, and regulatory audits (FDA, EMA, etc.)Act as a subject matter expert (SME) for raw material testing methods and regulatory expectationsTroubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) resultsLead or support method transfers, verifications, and validations for raw material assaysEvaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreementsIdentify opportunities to improve testing efficiency, data integrity, and complianceSupport implementation of new technologies, methods, and systemsParticipate in cross-functional teams with QA, Manufacturing, Materials Management and Product DevelopmentCoordinate 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 methodsKnowledge 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 applicationExcellent 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.
About the company
Company website•Biotechnology Research and Pharmaceutical Manufacturing
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.