Principal QC Specialist

Posted 12 Days Ago
Be an Early Applicant
Redwood City, CA
135K-165K Annually
Senior level
Biotech
The Role
The Principal QC Specialist will develop and build a new QC testing laboratory, establish sample management systems, perform technical reviews of GMP methods, draft QC-related documents, and lead QC GMP compliance activities.
Summary Generated by Built In

Who We Are

Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

What Matters to Us

Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.

Arcellx Core Values

  • Character: Committed to always doing what’s right.
  • Audacity: Willing to challenge convention and share candid feedback with others.
  • Determination: Curious and self-motivated. Always looking to improve and learn.  
  • Collaboration: "No job is too small" mentality. Humble and willing to help others.
  • Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.

How You’ll Make a Difference

As a Principal QC Specialist in our Quality Control group in Redwood City, you will have a direct impact on the Arcellx drug pipeline, both as a thought leader and a lab-based contributor. Our potentially life-saving treatments would not exist without the work of our talented scientists  and specialists. Your work will have a direct impact on our ability to deliver our transformative therapy to patients who need it most.

The “Fine Print” – What You’ll Do

  • Collaborate with teammates to develop and build our new QC testing laboratory from the ground up.
  • Establish sample management and chain of custody program, laboratory management system, and data backup system.
  • Perform technical review of GMP method qualification, method transfer, analytical testing associated with the batch release, stability and product characterization.
  • Draft and develop QC related SOPs, protocols, reports, impact assessments and root cause analysis.
  • Be a subject Matter Expert (SME) for the QC assays, especially molecular based assays.
  • Lead and approve for QC GMP Quality Management Systems, including Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls.
  • Coordinate activities to establish equipment/instrument qualification and validation program to meet the quality standards.

What We Look For

  • Bachelor’s degree in relevant field (e.g. immunology, cellular biology and molecular biology). Advanced degree preferred.
  • Minimum of 12 years (with BS), 10 years (with MS), or 7 years (with PhD) of experience in Quality Control or related areas within the biotech or pharma companies.  
  • Expertise in molecular-based assays.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
  • Strong collaboration, communication, and interpersonal skills. Demonstrated ability to influence within a matrix team structure.
  • Strong knowledge of cGMP/ICH/FDA regulations.

Rewards at Arcellx

Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.

The base salary range for this position is $140,000 - $170,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.

Our market-leading 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, 401k employer contribution and more. 

Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.

 #LI-Onsite

The Company
HQ: Gaithersburg, MD
93 Employees
On-site Workplace

What We Do

We are a clinical-stage biotechnology company reimagining cell therapy through the development of innovative immunotherapies.

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