Senior Director/Vice President, Analytical Development

My client is a clinical stage company focused on allogeneic / off-the-shelf CAR-T. Founded in 2017, they aim to develop the world’s leading allogeneic cell therapy products to address some of the most challenging the unmet needs.

In March 2020, the company received IND approval, marking the first UCAR-T IND in China. In January 2023, our CD7-targeted UCAR-T received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of T-ALL. This groundbreaking flagship asset has been dosed in nearly a hundred patients in an Investigator-Initiated Trial (IIT) clinical study, demonstrating excellent efficacy and safety. They are advancing the global clinical trial for this pipeline.

My client is searching for a Senior Director/Vice President of Analytical Development, reporting directly to the CEO, responsible for providing technical and management leadership supporting my client’s CAR-T programs. This role will lead a scientifically diverse team of highly skilled analytical scientists to develop through several INDs, BLA filings, approvals, label extensions, and life cycle management efforts in several drug product presentations. In addition, the person in this role is expected to work closely with internal and external resources to oversee analytical activities at various contract test laboratories and CMOs.

Responsibilities:

• Oversee analytical method development, transfer, validation, and operations, including release and stability studies, for drug substance, drug product, and finished products.

• Provide oversight for contract analytical services and the transfer of analytical methods to CRO and CMO partners.

• Review and approve relevant analytical documents, including method validation protocols/reports, specifications, and comparability protocols.

• Guide the team on various technical issues.

• Escalate significant analytical issues to management and project teams promptly, drive

mitigation or problem-solving activities.

• Provide technical support for regulatory filings, health authority questions, change control, and

quality impact assessments.

• Build collaborative relationships with key internal team members (Quality, Manufacturing,

Process Development, Translational Development, Formulation Development, and Drug Product

Development), stakeholders, and external customers.

• Lead development of next-generation assays for early and late-stage programs.

• Analyze, interpret, and present data to internal and external audiences.

Qualifications:

• Ph.D. degree in Biochemistry, Biology, Chemistry, or other relevant scientific disciplines with 10 to 14 years of experience or MS degree with 15+ years of analytical development experience in a Pharmaceutical, Biotechnology, or CDMO organization.

• Previous experience with assay qualifications and validation is required.

• Good understanding of cGMP manufacturing guidelines.

• Prior experience with tech transfer of assays.

• Experience with aseptically produced products is a plus.

• Demonstrated track record leading and managing high-performing teams with interdisciplinary touch points (Quality, Manufacturing, Process Development, Translational Development, Formulation Development, and/or Drug Product Development).

• Effective communication skills.

• Strong work ethic.