Associate I/II, Quality Control Environmental Monitoring (Contract to Hire)

About Artiva: 

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

For more information, visit www.artivabio.com.

Job Summary:

Artiva Biotherapeutics seeks a skilled and motivated QC Associate I or II for Environmental Monitoring (Contract to hire), to support the Quality Control environmental monitoring program and report to the Manager, Quality Control. This role is responsible for monitoring and assessing the cGMP manufacturing environment to detect, quantify, and help identify potential contaminants that could impact product quality. Key responsibilities include performing viable and non-viable air monitoring, surface bioburden sampling, gowning qualifications, and growth promotion testing of media used in biopharmaceutical manufacturing. 

Duties/Responsibilities:

• Perform testing for Artiva’s cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring utilizing proper aseptic techniques.
• Perform Gowning Qualifications for personnel requiring access to the cGMP facility.
• Coordinate EM support with manufacturing operations.
• Utilize an electronic database system for EM sampling.
• Perform growth promotion testing to support the release of EM media.
• Accurately document, review and trend EM data within GMP electronic database; identify adverse trends and escalate findings to management.
• Support EM excursions and out-of-trend events, including root cause analysis, impact assessment and CAPA.
• Assist in revising SOP’s, test forms, logbooks, and technical documents to support the EM program.
• Maintain records and databases in accordance with procedures.
• Perform routine maintenance, cleaning and upkeep of laboratory equipment to ensure operational readiness.
• Maintain adequate inventory of test supplies and order laboratory materials.
• Troubleshoot assay and instrument problems.
• Maintain records and databases in accordance with procedures.
• Adhere to all safety requirements, performing work in compliance with OSHA regulations and company safety policies.

Qualifications:

• Bachelor’s (BA/BS) in Microbiology or related scientific discipline.
• At least 1-3 years of cGMP QC experience in cell therapy/biotech/pharmaceutical industry.
• Experience in EM programs, including data trending, excursion management and regulatory expectations is preferred.
• Experience with aseptic techniques and adherence to cGMP gowning and hygiene practices.
• Excellent critical thinking, problem solving, and technical writing skills.
• Excellent interpersonal and communication skills to facilitate and follow.

• Proficiency with electronic systems and Microsoft Office applications (Word, Excel, etc).

We look for talented, entrepreneurial people who share our values.

We are called to put the safety of our patients and employees first, and to act with integrity and the highest ethical standards. To achieve our mission, we must collaborate across the Company at all levels, and we must hold ourselves and our teams accountable for delivering the progress we commit to, on the timelines we set. We embrace diversity, we include people and their ideas, and we aspire to excellence by listening, understanding, sharing, and responding. We want you to be fully engaged, to develop personally and professionally through this chapter in your life, and to have fun along the way. 

Artiva Biotherapeutics is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. 

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!

This position is a contractor role with the potential to convert to a full-time position.

Base Salary: $74,000 - $80,000. Exact compensation may vary based on level, skills and experience.