Director, Analytical Development & QC - Cell & Gene Therapy

cincinnatichildrens; Cleveland (OH); On-site; USD 126,000 - 164,000; Full time

Job summary

Cincinnati Children's is seeking an experienced leader to head Analytical Development and Quality Control for cell and gene therapy programs. You will plan budgets, guide a high-performing team, and partner with CDMOs/CTLs to oversee outsourced analytics.

Deliver scientific leadership, develop policies and master production records, and drive compliance with GMP/ICH guidance. This role requires a strong track record in regulatory submissions and cross-functional collaboration.

Qualifications

• Master's degree in Biochemistry, Molecular Biology, Cell Biology or related discipline.
• 7+ years in biopharmaceutical analytical development and quality control, preferably in cell/gene therapy.
• Hands-on with qPCR/ddPCR, ELISA, flow cytometry, cell-based assays, viral titering, NGS, immunoassays.
• Strong GMP/ICH knowledge and regulatory expectations for advanced therapy products.
• Proven leadership in building and managing technical teams; regulatory submission experience.

Responsibilities

• Lead AD/QC for cell and gene therapy programs; oversee GMP QC testing and method validation.
• Plan annual budget for AD/QC; supervise performance and vendor relationships with CDMOs/CTLs.
• Provide SME for regulatory interactions, audits, and submissions (IND/IMPD/BLA/MAA).
• Develop and implement analytical control strategies across product lifecycle.

Skills

Leadership

Communication

Project management

Regulatory experience

Strategic thinking

Education

Master's Degree in Biochemistry / Molecular Biology / Cell Biology

Tools

qPCR/ddPCR

ELISA

flow cytometry

cell-based assays

viral titering

NGS

immunoassays

Job description

Cincinnati Children's is seeking an experienced leader to head Analytical Development and Quality Control for cell and gene therapy programs. You will plan budgets, guide a high-performing team, and partner with CDMOs/CTLs to oversee outsourced analytics.

Deliver scientific leadership, develop policies and master production records, and drive compliance with GMP/ICH guidance. This role requires a strong track record in regulatory submissions and cross-functional collaboration.