Manufacturing Associate

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

The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in our new, state of the art, cGMP facility. The successful candidate will develop and adhere to written procedures (SOPs) related to GMP facility operations, monitoring of equipment and facilities, and manufacturing of cell therapies internally

Job Summary

The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in our new, state of the art, cGMP facility. The successful candidate will develop and adhere to written procedures (SOPs) related to GMP facility operations, monitoring of equipment and facilities, and manufacturing of cell therapies internally at Artiva. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance and will support manufacturing activities across multiple programs. 

Duties/Responsibilities

• Assist in setting up cGMP manufacturing suites and equipment/fixtures as needed.

• Perform facility and equipment monitoring activities.

• Assist in authoring manufacturing standard operating procedures and batch production records that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

• Perform cGMP manufacturing and support operations described in standard operating procedures and batch records across multiple programs.

• Complete documentation required by process tech-transfer protocols, validation protocols, standard operating procedures, and batch records following cGDP standards.

• Perform tasks in a manner consistent with Artiva’s safety policies, quality systems, and GMP requirements.

• Complete training assignments and qualifications to ensure the necessary GMP manufacturing, and process related technical skills and knowledge.

Required Skills & Experience

• Bachelor’s degree in relevant science or engineering discipline, or equivalent work experience.
• Minimum 2 years of experience in cGMP biologics or cell culture manufacturing, experience in biotech or cell therapy manufacturing preferred.
• Experience in the following preferred:
• Aseptic gowning and manufacturing in an ISO 7 clean room environment.
• 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.
• Experience with transduction using Lentiviral vectors
• Cell harvesting and washing processes both automated and manual. Experience with kSep a plus.
• Cell selection and depletion techniques using Miltenyi CliniMACS Prodigy.
• Fill finish and Cryopreservation processes and equipment in both bags and vials. AT-vialing a plus
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

• Will require working with cells and cell lines of human origin as well as viral vectors
• Position may require occasional weekend or evening work at Artiva.

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 - $95,000. Exact compensation may vary based on skills and experience.