Sr. Associate, Quality Control (Environmental Monitoring)

About Artiva:

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.

Job Summary:

Artiva Biotherapeutics is seeking a skilled and motivated Quality Control Senior 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 Environmental Monitoring 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, release testing of microorganisms and growth promotion of media in biopharmaceutical manufacturing.

Duties/Responsibilities:

• Leads testing for Artiva’s cGMP EM program, including non-viable particulate monitoring, viable air and surface monitoring.
• Coordinates with Manufacturing for monitoring cGMP processes
• Utilizes an electronic database system for QC EM.
• 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.
• General maintenance and cleaning of laboratory equipment.
• Troubleshoot assay and instrument problems.
• Authors and revises SOP’s, test forms, logbooks, and investigations for EM excursions.
• Supports special projects, e.g., Disinfectant Efficacy Studies, risk assessments, smoke studies and/or cleaning validation.
• Updates EM trending data and assists with writing quarterly summary reports.
• Manages EM inventory and ordering of materials.
• Assists with writing technical QC protocols and reports as needed.
• Maintain records and databases in accordance with procedures.
• Working in a safe manner, which is compliant with OSHA and company safety policies.

Qualifications:

• Bachelor’s in microbiology or relevant scientific field.
• At least 4-7 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• cGMP environmental monitoring experience is expected.
• Aseptic technique or tissue culture experience is a plus.
• 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 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: $86,000 - $112,000. Exact compensation may vary based on skills and experience.