Head of Analytical Development & QC, Cell & Gene Therapy

Cincinnati Children's Office of Academic Affairs and Career Development; Cincinnati (OH); On-site; USD 126,000 - 164,000; Full time

Job summary

Cincinnati Children's is seeking a senior leader to steward Analytical Development and Quality Control for cell and gene therapy programs. You will guide method development, regulatory planning, and cross-functional collaboration with external CDMOs and CTLs to ensure quality and compliance.

The role emphasizes strategic leadership, mentorship of teams, and regulatory readiness across IND/IMPD/BLA/MAA submissions, with a focus on building robust analytics and partnerships.

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 and gene therapy.
• Hands-on experience with analytical technologies (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.
• Experience authoring analytical CMC sections for regulatory submissions.

Responsibilities

• Fiscal: plan the annual budget for Analytical Development and Quality Control (AD/QC); represent AD/QC for contract negotiating.
• Planning and Program Development: mentor a high-performing AD/QC team, collaborating with CDMO/CTL partners and overseeing outsourced AD/QC activities.
• Leadership: lead and manage AD/QC for all cell and gene therapy programs; SME for regulatory interactions, audits, and submissions.
• Operations and Compliance: develop, qualify, and transfer analytical methods; oversee GMP QC testing and regulatory readiness.

Skills

Analytical technologies

Leadership

Communication skills

Regulatory knowledge

Education

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

Tools

CDMOs/CROs experience

Job description

Cincinnati Children's is seeking a senior leader to steward Analytical Development and Quality Control for cell and gene therapy programs. You will guide method development, regulatory planning, and cross-functional collaboration with external CDMOs and CTLs to ensure quality and compliance.

The role emphasizes strategic leadership, mentorship of teams, and regulatory readiness across IND/IMPD/BLA/MAA submissions, with a focus on building robust analytics and partnerships.