Senior Manager, Quality Control

Posted 2 Days Ago
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Redwood City, CA
Senior level
Biotech
The Role
Lead QC activities, analyze data, review GMP methods, support regulatory submissions, and interact with cross-functional teams to ensure product release meets quality standards.
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.

The “Fine Print” – What You’ll Do

  • Lead and oversight of QC activities at CDMOs and external testing labs in support of product release on accelerated timelines.
  • Analysis and critical evaluation of analytical data, statistical analysis and trend analysis.
  • Perform technical review of GMP method qualification, method transfer, analytical testing associated with the batch release and stability programs.
  • Review QC related SOPs, protocols, reports, impact assessments and root cause analysis.
  • Support QC GMP Quality Management Systems, including but not limited to Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls.
  • Interact effectively with cross functional teams and solve testing related issue.
  • Provide support with regulatory submissions (IND/BLA).

We Look For

  • Bachelor’s degree in immunology and cellular biology or a related discipline, and at least 5+ years (with PhD) or 8+ years (with BS) of relevant experience in AD/QC.
  • Analytical CMC development, method transfer, stability programs and CRO/CDMO management is highly desirable.
  • Fundamental understanding of statistics and data analysis software, such as JMP.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
  • Detail-oriented individual with strong analytical and problem-solving skills.
  • 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 - $165,000 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

Top Skills

Jmp
Statistical Analysis Software
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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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