Associate, Quality Control, Environmental Monitoring

About Artiva:

Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.

Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically  modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).

AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in

patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.

Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.

For more information, visit www.artivabio.com.

Job Summary:

Artiva Biotherapeutics is seeking a skilled and motivated Quality Control Associate for Environmental Monitoring (EM) who will be reporting to the Supervisor of Quality Control. This individual will support the Quality Control department for the EM program at Artiva. This person will be responsible for detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product. Major areas of responsibility include the performance of viable and non-viable air testing, surface bioburden testing, gowning qualifications, release testing of microorganisms, and growth promotion of media in biopharmaceutical manufacturing.

Duties/Responsibilities:

·         Perform testing for Artiva’s cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring using aseptic technique.

·         Perform Gowning Qualifications for personnel requiring access to the cGMP facility.

·         Coordinate with Manufacturing for EM of cGMP processes.

·         Utilize an electronic database system for QC EM sampling.

·         Perform growth promotion testing for EM media release.

·         Review EM Data.

·         Record and trend data in a GMP electronic database.

·         Maintain adequate inventory of test supplies and ordering laboratory materials.

·         General maintenance and cleaning of laboratory equipment.

·         Troubleshoot assay and instrument problems.

·         Assist in revising SOP’s, test forms, logbooks, and investigations for EM excursions.

·         Assist with writing technical QC protocols and reports as needed.

·         Maintain records and databases in accordance with procedures.

·         Working in a safe manner that is compliant with OSHA and company safety policies.

Qualifications:

·         Bachelor of Science (BS) in microbiology or relevant scientific field.

·         At least 2-4 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.

·         cGMP environmental monitoring experience is expected.

·         Aseptic technique experience is a plus.

·         Excellent critical thinking and technical writing skills.

·         Excellent interpersonal and communication skills to facilitate and follow.

·         Computer skills required to operate Microsoft Word and Excel programs. 

Why you should apply:

We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.  We are innovative - pushing into new frontiers for patient benefit.  We are transparent - believers in flat, accessible, and open communication paths.  We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.

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.

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

Base Salary: $75,000 - $90,000 Exact compensation may vary based on skills and experience.

Salary : $75,000 - $90,000