Manager, GMP Quality Operations

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing Phase 1 study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: a Phase 1 study of ACLX-001 for r/r MM, initiated in the second quarter of 2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, expected to enter the clinic in the second half of 2022.

Arcellx is looking for a Manager, GMP Quality Operations to be responsible for supporting the quality assurance program. Reporting to the Director of GMP Quality Operations, the manager will provide day to day quality support to the various Arcellx GMP-relevant functions and will be responsible for the administration of quality standards, internal practices and continuous improvement as it relates to internal technical operations and collaborations with manufacturing vendors.

At Arcellx, we value passion, curiosity, determination, and diversity, and look for candidates who demonstrate a genuine interest in our mission and alignment with our values.  

Key Responsibilities: 

• Support management quality reviews and product reviews.
• Lead the review and release of clinical trial material for on-going and future studies.
• Create, review, and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols, etc.
• Coordinate investigations, including development and implementation of corrective actions.
• Manage change control review and implementation with internal and external stakeholders.
• Support internal and external audits.
• Collaborate with cross functional team member to resolve quality issues.
• Assist with validation activities related to facilities, equipment, processes, and computerized systems at contract sites.
• Support the collection of key quality metrics.
• Communicate and promote a culture of quality and operational excellence at Arcellx.

Qualifications: 

• Bachelor's degree in a scientific or technical discipline is required. An advanced degree is preferred.
• Experience in a GxP biotechnology or pharmaceutical environment is required. Biologics/cell therapy experience preferred.
• Knowledge and experience in quality assurance and in a highly regulated manufacturing environment.
• Experience working with Contract Manufacturing Organizations.
• Experience with regulatory inspections preferred.
• Extensive knowledge of US cGMP and GDP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Ability to manage multiple priorities and aggressive timelines.

Competencies:

• Has character and integrity. Committed to always doing what’s right.
• Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
• "No job is too small" mentality. Humble and willing to help others.
• Able to build strong relationships and collaborate effectively with colleagues.
• Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
• Always looking to improve and challenge the status quo. Gritty and determined.