Analytical Scientist (Contractor)

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 talented and experienced contractor to join the Analytical Development group within Cell Process Sciences in Gaithersburg, MD, supporting CMC 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 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.

The successful candidate will lead projects to deliver analytical results and methods for CMC programs. In this role, strong assay development, experimental design, and troubleshooting skills are a must.  The ability to work on multiple projects with minimal supervision and to clearly communicate results to cross functional teams is critical. We are looking for candidates who can  make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experimental data. 

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:

• Develop and optimize analytical methods to assess product identity, purity, potency, and safety tests.
• Design and implement testing strategies to conduct characterization and comparability studies.
• Participate in method transfers with CMOs.
• Provide analytical support to process development and research and discovery teams.
• Troubleshoot and perform routine maintenance of lab equipment such as flow cytometer and plate readers.
• Uses DOE and statistical methods to design effective experiments.
• Thoroughly analyze results and methods, track/trend control data, solve analytical problems, and troubleshoot assays.
• 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 0-3 years of relevant experience in biopharmaceutical development.
• Thorough understanding of analytical fundamentals including accuracy, precision, linearity, and robustness.
• Practical and demonstrated experience with flow cytometry and cell-based assays is required.
• 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 desired.

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.

Salary Range: $136,000 - $160,000 per year.