Principal Scientist, Product Sciences

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 seeking a Principal Scientist to join the Cell Process Sciences (Product Sciences team) in Redwood City, CA to support CMC development of therapeutic proteins and lead projects to deliver analytical results and methods for CMC programs. In this role, the Principal Scientist will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experimental data.

Successful candidates must be motivated, energetic, and detail-oriented, with experience in analytical method development, characterization, and comparability assessment of cellular therapeutics. A solid understanding of principles and practical applications of flow cytometry, cell enumeration and viability, and cell-based potency assays is required. The ideal candidate will have a strong background in cell characterization and hands-on experience in developing and optimizing bioassays for specificity, linearity, range, accuracy, precision, and other analytical attributes.

Additional critical skills for this role are assay development, experimental design, troubleshooting, ability to work autonomously on multiple projects at a time, and clearly communicating results to cross functional team members.  

Key Responsibilities: 

• Lead Product Sciences team in delivery of CMC/clinical correlative analysis to inform CQAs, integration site analysis, and other product characterization studies.
• Drive development of integrated scientific/technical strategy to inform the development of biological hypotheses relating to product cellular attributes and their impact on clinical outcomes, manufacturing, and development of analytical tools.
• Coordinate with Cell Biology, Translational Sciences and Analytical Development on characterization of cell products, intermediates and starting material.
• Design and implement testing strategies to conduct characterization and comparability studies.
• Support CMC goals by providing biological and technical knowledge across program and platform.
• Establish correlation of surrogate potency assay to biological MOA.
• Able to establish and maintain Product Sciences laboratory.
• Author/ co-author and review reports, SOPs, and CMC documentation.
• Follow good documentation practices to ensure data accuracy, integrity, and good record keeping.

Qualifications: 

• Ph.D. with 5+ years of relevant experience or master’s degree with a minimum of 10 years of experience in an academic and/or industrial setting.
• Deep understanding of T cell biology.
• Extensive experience in mammalian cell culture and methods for immune cell characterization.
• Practical and demonstrated experience with advanced statistical tools.
• Ability to critically analyze data, to communicate results, and to author technical reports.
• Excellent record keeping abilities to document analytical data generated in support of regulatory requirements.
• Ability to work effectively in cross-functional groups.
• Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of biotherapeutics products is preferred but not required.

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.