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

Artiva Biotherapeutics · San Diego, CA · 1 wk ago
On-siteInformation Technology$74k–$80k/yrContract

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.

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.
  • Adhere to all safety requirements, performing work in compliance with OSHA regulations and company safety policies.

Requirements

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

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • 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.
  • Recognition program (Bonus.ly) where points can be redeemed for rewards.

Pay

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

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

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