About Artiva:

Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artiva’s pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH. Artiva’s AlloNK™ platform incorporates cell expansion, activation, and engineering 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.

Job Summary:

Artiva Biotherapeutics is seeking a skilled and motived Quality Control Manager for Environmental Monitoring (EM) who will be reporting to the Director of Quality Control. This individual will manage and oversee the Quality Control department for the Environmental Monitoring program at Artiva. This person will be responsible for interpreting regulations and ensuring compliance to departmental policies and procedures. Perform high level QC EM data analysis and serve as the technical resource for the QC department. Interface with Manufacturing, Facilities and Quality Assurance leadership and participate/lead in interdepartmental teams to address quality-related issues.

The Location:

Artiva Headquarters in San Diego, CA

What you'll do:

• Manage and oversee Artiva’s CGMP EM program.
• Evaluate QC systems and recommend and/or implement system improvements.
• Conduct risk assessments for reduction of sites of the EM program and recommend site improvements.
• Manage and oversee special projects, e.g., Disinfectant Efficacy Studies, EMPQ, smoke studies and or cleaning validation.
• Conduct EM investigations and write reports for Alert/Action of EM.
• Manage EM trending data and write quarterly summary reports.
• Oversee and manage Contract Labs in regards in EM testing.
• Oversee and manage the implementation of Artiva’s EM program.
• Collaborate with Manufacturing for monitoring CGMP processes and plan schedules for EM analysts.
• Write, revise, and manage EM SOPs and forms that support Artiva’s cell therapy products.
• Write technical QC protocols and reports as needed.
• Evaluate electronic database systems and implement into QC EM.
• Maintain records and databases in accordance with procedures.

What you will bring:

• BS/Master’s in microbiology or relevant scientific field.
• At least 10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• At least 3 years of management experience is required.

• Basic knowledge of qualifications and validations; current industry practices; and strong experience with guidance interpretation and application.

• Experience with risk assessment tools is desired (FMEA, Fish Bone, 6Ms, etc.)
• Excellent critical thinking and technical writing skills.
• Excellent interpersonal and communication skills to lead, facilitate and follow.

• Computer skills required to operate Microsoft Word, Project, Visio, 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 cancer 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 new 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!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: 115,000 - $149,500. Exact compensation may vary based on skills and experience.