Director, Analytical Development & QC - Gene Therapy

Cincinnati Children's; Cincinnati (OH); On-site; USD 126,000 - 164,000; Full time

Job summary

Cincinnati Children's is seeking a senior leader to oversee Analytical Development and Quality Control for cell and gene therapy programs. The role includes leading AD/QC, regulatory interactions, and collaboration with external CDMOs and CTLs, ensuring GMP/ICH compliance and robust analytics.

The successful candidate will mentor a high-performing team, develop method transfers, and support regulatory submissions (IND/IMPD/BLA/MAA) while driving continuous improvement across all lab operations

Qualifications

• Master's degree in Biochemistry, Molecular Biology, Cell Biology or related discipline.
• 7+ years relevant experience in biopharmaceutical analytical development and quality control.
• 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.
• Excellent communication, organizational, and project management skills.
• Experience with external CDMOs/CROs and testing labs (preferred).

Responsibilities

• Fiscal - Plan the annual budget for Analytical Development and Quality Control; represent AD/QC for contract negotiating.
• Planning and Program Development - Develop and mentor a high-performing AD/QC team; oversee outsourced AD/QC activities.
• Leadership - Lead and manage the AD/QC function for all cell and gene therapy programs; provide SME for regulatory interactions, audits, and inspections; lead analytical support for regulatory submissions.
• Operations and Compliance - Develop, qualify, and transfer analytical methods; oversee GMP QC testing; ensure compliance with regulatory standards; drive improvements.

Skills

Analytical development

Quality control

Leadership

CMC regulatory submissions

GMP/ICH knowledge

Team management

External CDMO/CDLO collaboration

Communication & project management

Education

Master's Degree in Biochemistry, Molecular Biology, Cell Biology or related discipline

Job description

Cincinnati Children's is seeking a senior leader to oversee Analytical Development and Quality Control for cell and gene therapy programs. The role includes leading AD/QC, regulatory interactions, and collaboration with external CDMOs and CTLs, ensuring GMP/ICH compliance and robust analytics.

The successful candidate will mentor a high-performing team, develop method transfers, and support regulatory submissions (IND/IMPD/BLA/MAA) while driving continuous improvement across all lab operations