Principal Quality Control Specialist

2 weeks ago

Redwood City, California, United States Arcellx, Inc. Full time
About Arcellx, Inc.

Arcellx, Inc. is a pioneering biotechnology company dedicated to revolutionizing cell therapy for patients with cancer and other life-threatening diseases. Our mission is to develop innovative immunotherapies that are safer, more effective, and more accessible.

Job Title: Principal QC Specialist

We are seeking a highly skilled Principal QC Specialist to join our Quality Control team in Redwood City. As a key member of our team, you will play a critical role in ensuring the quality and integrity of our cell therapies.

Key Responsibilities:
  • Collaborate with cross-functional teams to develop and implement quality control strategies and procedures.
  • Establish and maintain a robust quality management system, including laboratory management, data backup, and chain of custody.
  • Perform technical reviews of GMP method qualification, method transfer, and analytical testing.
  • Draft and develop quality-related SOPs, protocols, reports, and impact assessments.
  • Lead and approve quality management systems, including lab investigations, OOS/OOTs, deviations, CAPAs, and change controls.
  • Coordinate equipment/instrument qualification and validation programs to meet quality standards.
Requirements:
  • Bachelor's degree in a relevant field (e.g., immunology, cellular biology, molecular biology). Advanced degree preferred.
  • Minimum of 10 years (with BS), 8 years (with MS), or 5 years (with PhD) of experience in Quality Control or related areas within the biotech or pharma industry.
  • Expertise in molecular-based assays.
  • Excellent organizational skills and ability to prioritize effectively to deliver results within aggressive timelines.
  • Strong collaboration, communication, and interpersonal skills.
  • Strong knowledge of cGMP/ICH/FDA regulations.
What We Offer:

Arcellx, Inc. offers a competitive compensation package, including a base salary range of $140,000 - $170,000 per year, annual bonus, and equity (RSU) grant. Our benefits package includes 100% coverage for medical, dental, and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, and 401k employer contribution.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about cell therapy and committed to excellence, we encourage you to apply for this exciting opportunity.

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