PRIMARY OBJECTIVE: The candidate will bring to the role a strong understanding and demonstrated expertise with the latest cell therapy analytical technologies, method development/qualification/validation, and GMP Quality Control. His/her functions will include but are not limited to: the development, qualification and validation of methods for GMP release of cell therapies and vector technologies, the technology transfer of methods to CMOs, establishing and maintaining quality controls to assure method reliability through development and manufacturing. The successful candidate will be responsible for working across functional areas such as research, development, clinical, regulatory, and manufacturing to enable critical decisions across the Arcellx portfolio.
ABOUT ARCELLX: Arcellx (http://arcellxdev.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The main responsibilities will include but are not limited to:
- Provide management and accountability for the generation of GMP methods to enable clinical cell and vector manufacturing.
- Provide senior scientific leadership and set strategic direction of technology advancement.
- Manage development, qualification, and validation of GMP assays for identity, purity, viability, strength and potency.
- Lead analytical development team in the development of high-quality product and in-process analytics, ensuring compliance with regulatory guidelines. Review and finalize SOPs, protocols, method validations, stability studies and analytical reports that meet all applicable regulatory requirements.
- Work closely with research/preclinical teams to identify relevant assays suitable for GMP adaptation for all cell and vector quality attributes.
- Work closely with process development and protein science teams to deliver analytical results for process decision making and regulatory needs.
- Work closely with CMO QC and manufacturing teams to ensure assay control in GMP environment.
- Review and approve sample collection procedures, storage and transmission specifications for GMP protocols, system suitability controls, assay raw material specifications, and all GMP test methods at Arcellx and CMOs.
- Conduct comparability assessment (as needed) for any changes made to qualified/validated assays.
- Contribute to relevant analytical sections of IND/BLA and other regulatory documents.
- Strong scientific and operational background in implementation of flow-based assays, molecular biology assays and microbiological safety assays
- Strong understanding of method validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance.
- Interact closely with other Arcellx team members to ensure that analytical activities are prioritized appropriately and the deliverables are achieved in a timely manner.
- PhD in Chemistry, Biochemistry, Pharmacology or Analytical Science with 8 or more years of pharmaceutical industry experience and a demonstrated technical leadership in analytical research and development, or MS/BS with 12+ years of relevant experience.
- Proven ability to provide analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies.
- Experience working in a GMP regulated environment.
- Strong scientific and operational background in the optimization and validation of immunochemical and cell-based assays.
- Experience managing individual contributors.
- Strong understanding of method development, technical transfer, and GMP requirements.
Experience with IND and/or BLA submissions.
- Detail oriented, exceptional documentation practices, technical writing and verbal communication skills.
- Demonstrated effective interpersonal, communication and negotiation skills for a wide variety of audiences, including senior leaders.
- Courage to lead and make tough decisions/strong influencing skills.
- Maintaining a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.
- Excellent contingency planning and time management skills and demonstrated ability to manage several projects simultaneously.
- Possess strong problem solving and analytical skills and be an independent and creative thinker.
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.