Associate Director, Technology Transfer and MSAT

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 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: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

We are looking for a talented and highly motivated Associate Director, Technology Transfer and MSAT to join our fast-growing late-stage commercial MSAT team in Redwood City, California. We aspire to be the leaders in cell therapy manufacturing using novel and best in class manufacturing technology to deliver for patients every time. MSAT provides technical leadership to develop robust, innovative, and cost-effective solutions for commercialization and life cycle management of cell therapy products. The technology transfer and MSAT role is a highly visible and impactful role in the Technical Ops organization.    

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 Job Responsibilities: 

• Provide technical leadership for T-cell manufacturing process changes, process validation, comparability assessment, discrepancy/ deviation, and investigation evaluations, change control, and regulatory submissions.
• Responsible for technology transfers of T-cell processes to Contract Manufacturing Organizations as technical SME as well as to internal network sites. Ensure robust production in GMP environment.
• Provide technical input for facility selection, design input and due diligence support for Pivotal/ commercial manufacturing site selection.
• Own late stage/ commercial T-cell processes, drive manufacturing innovation and work collaboratively to ensure continuous improvement, and consistency of processes implemented across the manufacturing network.
• Responsible for authoring technical reports, reviewing, and approving manufacturing batch records, process validation documents and relevant portions of regulatory submissions to support licensing processes at new/ existing manufacturing sites.
• Supervise/ conduct lab work to resolve investigations and/or to demonstrate proof-of-concept for proposed changes
• Lead / Represent MSAT on initiatives led by partner groups such as Process Development, Analytical Development, Quality, Regulatory, Manufacturing Operations etc.
• Build strong relationships and alignment with internal/ external (CMO) partners. Ensure effective communication across the networks for swift resolution of technical issues and escalation as needed.
• Travel (up to 25%) to contract manufacturing sites and Arcellx internal sites will be required.

Qualifications: 

• Bachelor’s plus 10+ years’ experience / Master’s plus 8 + years’ experience / PhD plus 5+ years’ experience in a technical discipline (e.g., biochemical/ chemical engineering, biotechnology or equivalent) with relevant experience in pharmaceutical development and manufacturing of biological drugs.
• Experience in process development or technology transfer and manufacturing technical support of cell and gene therapies is preferred.
• Strong working knowledge of FDA regulations (GMP) and industry standards.
• Prior experience working with CMOs and project management skillset is a plus.
• Excellent collaboration, communication skills and ability to influence across multiple functions to get the job done.

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.