MSAT Scientist II

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 Scientist II to join our fast-growing MSAT team. We aspire to be 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 Scientist II 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 Responsibilities:

• Provide technical expertise for T-cell manufacturing process changes, comparability assessment, discrepancy/ deviation, and investigation evaluations, change control, and regulatory submissions.
• Assist in technology transfers of T-cell processes to Contract Manufacturing Organizations as well as to internal network sites. Ensure robust production in GMP environment.
• Technical SME (superuser) for one or more unit operations in T-cell processes, lead process improvements and process monitoring (trending) to ensure consistency of processes implemented across the manufacturing network.
• Responsible for authoring technical reports, reviewing, and approving manufacturing batch records, SOP’s and contributing to regulatory submissions to support licensing processes at new and existing manufacturing sites.
• Develop experimental plans and conduct lab work to resolve investigations and/or to demonstrate proof-of-concept for proposed changes.
• Assist in Person-in-Plant (PIP) responsibilities (combination of remote and onsite support at CMO’s).
• Represent MSAT on initiatives (e.g. process characterization, closed processing, process automation, method changes etc.) led by partner groups such as Process Development, Analytical Development, Quality, Regulatory, Manufacturing Operations, etc.
• Communicate effectively on assigned projects to ensure 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: 

• Bachelors plus 7+ years’ experience; masters plus 5 + years’ experience; PhD plus 2+ years’ experience in a technical discipline (e.g., biochemical/ chemical engineering, biotechnology or equivalent) with relevant experience in pharmaceutical development and/or manufacturing of biological drugs.
• Experience in cell culture, aseptic processing, use of single use system and automation technologies is preferred.
• Practical experience with statistical tools (JMP, GraphPAD Prism, SAS etc.) and statistical process control is preferred.
• Prior experience working with CMO’s on technology transfer and manufacturing technical support for cell and gene therapies or biologics manufacturing is a plus.
• Working knowledge/ understanding of FDA regulations (GMP’s) and industry standards.

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.