Director of Analytical Development and Quality Control

Primary Location Canal Road Department Applied Gene and Cell Therapy Center Shift Day (United States of America) Schedule Full time Weekly Hours 40 FTE 1 Employee Status Regular
* Expected Starting Pay Range $ - $
* Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on-call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.

• Fiscal
  - Plan the annual budget for Analytical Development and Quality Control (AD/QC); represent AD/QC for contract negotiating.
• Planning and Program Development
  - Develop and mentor a high-performing AD/QC team, fostering innovation and scientific rigor.
• Collaborate with external Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL) partners and oversee outsourced AD/QC activities.
• Leadership
  - Lead and manage the AD/QC function for all cell and gene therapy programs. Working with both viral vector and cell team, developing methods and testing samples as needed. Provide scientific and technical leadership in assay development for viral vectors, cell-based products, gene-modified cells, and raw materials. Develop, approve & implement policies, SOPs, master production records, specifications, & certification plans for improved use, quality & operations.
  
  Proactively identify & implement areas for improvement. Develop & maintain productivity standards for all areas of the lab. Serve as the point of contact for the AD/QC department, internally and externally. Serve as Subject Matter Expert (SME) for regulatory interactions, audits, and inspections. Lead analytical support for comparability, tech transfer, and regulatory submissions (IND/IMPD/BLA/MAA).
• Operations and Compliance
  - Develop, qualify, and transfer analytical methods for identity, potency, purity, safety, and comparability. Oversee Good Manufacturing Practices (GMP) QC testing, including release and stability testing, in-house or at Contract Testing Labs (CTLs). Design and implement phase-appropriate analytical control strategies aligned with product lifecycle. Manage reference standards, critical reagent qualification, assay lifecycle and method validation per ICH/FDA/EMA guidance. Sustain a working understanding of regulatory requirements and accreditation standards.
  
  Evaluate area of responsibility for compliance with regulatory and accreditation standards. Identify best practices as well as deficiencies to share with peers and make recommendations for improvement. Participate in the development of corrective action plans to guide needed and sustainable improvements. Ensure that compliance and readiness plans are current. Enhance relationships to promote interdisciplinary involvement and knowledge of compliance standards, status, and actions.
  
  Track laws, regulations and standards that may affect practice and policies. Work with direct reports to ensure that needed changes are made by the effective date of any change(s) in requirements.

• Master's Degree in Biochemistry, Molecular Biology, Cell Biology or related discipline
• 7+ years relevant experience in biopharmaceutical analytical development and quality control, preferably in cell and gene therapy or biologics
• Hands-on experience with a broad range of analytical technologies (e.g., qPCR/ddPCR, ELISA, flow cytometry, cell-based assays, viral titering, NGS, immunoassays)
• Strong knowledge of Good Manufacturing Practices (GMP), International Community of Harmony (ICH) guidelines, and regulatory expectations for advanced therapy products
• Proven leadership experience with demonstrated success in building and managing technical teams
• Experience in authoring analytical Chemistry, Manufacturing and Control (CMC) sections for regulatory submissions and handling health authority queries
• Excellent communication, organizational, and project management skills
• Preferred:
  Experience with external Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and testing labs

At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's.

• Recognized by U.S. News & World Report as a top 10 best Children's Hospitals in the nation for more than 15 years
• Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH) Funding
• Recognized as one of America's Best Large Employers (2025), America's Best Employers for New Grads (2025)
• One of the nation's America's Most Innovative Companies as noted by Fortune
• Consistently certified as great place to work
• A Leading Disability Employer as noted by the National Organization on Disability
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