What are the responsibilities and job description for the Manufacturing Associate position at Artiva Biotherapeutics?
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
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.
Working Conditions and Physical Requirements
- 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 autoimmune and cancer patients. We are tenacious – we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. 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:
· 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 - $100,000. Exact compensation may vary based on level, skills and experience.