Principal Scientist, Analytical Development

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 team in Redwood City, California. supporting the analytical development of CAR-T therapies. Candidates must be motivated, energetic, and detail oriented, with experience in analytical method development, characterization, and comparability assessment of cellular therapeutics. Understanding of principles and practical applications of flow cytometry, cell enumeration and viability, and cell-based potency assays is required.

The ideal candidate will guide and oversee all aspects of analytical technical development activities at a CDMO, and other third-parties as necessary, including development of QTPP and robust analytical methods in support of the analytical control strategy and successful BLA filing.

The ideal candidate for this role is an individual who has a proven track record of innovation and publication and is excited to take on new challenges in a fast-paced and dynamic start-up environment. 

Key Responsibilities:

• Design and execute method development and qualification in support of process development, product release and stability, product characterization, investigation, and process performance qualification.
• Lead and oversight of analytical technical activities at a CDMO in support of product development on accelerated timelines, including late-stage product characterization, risk assessments, and establishment of QTPP and control of CQAs.
• Analysis and critical evaluation of analytical data, including technical review of reports authored at CDMO.
• Preparation and/or review of documents in support of CMC Regulatory BLA/ MAA filings and addressing queries from health authorities.
• Regular refreshment of activities plans for efficiency and speed to ensure timelines are maintained.
• Communication of activities to internal stakeholders to ensure understanding and alignment regarding status and risks.

Qualifications:

• PhD. or master’s degree in immunology and cellular biology or a related discipline, and at least 5+ years (with PhD) or 10+ years (with MS) of experience in late-stage analytical development for cell therapeutics.
• 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.
• Demonstrate a strong skill set and knowledge in analytical assay development and assay optimization.
• Design and implement testing strategies to conduct characterization and comparability studies.
• Strong collaboration and interpersonal skills, including verbal and written communication, and ability influence.
• Ability to work independently and as part of a matrixed team.

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.