Director of Analytical Development and Quality Control

Primary location: Canal Road, Applied Gene and Cell Therapy Center. Full-time position, 40 hours per week, day shift.

About Us

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.

Cincinnati Children's is 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, and recognized as one of America’s Best Large Employers (2025) and America’s Best Employers for New Grads (2025). We are also noted as one of the nation's most innovative companies by Fortune, a Leading Disability Employer by the National Organization on Disability, and a Magnet®-designated organization for the fourth consecutive time by the American Nurses Credentialing Center (ANCC).

Responsibilities

• Plan the annual budget for Analytical Development and Quality Control (AD/QC); represent AD/QC for contract negotiating.
• 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.
• Lead and manage the AD/QC function for all cell and gene therapy programs, working with both viral vector and cell teams to develop methods and test 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, and implement policies, SOPs, master production records, specifications, and certification plans for improved use, quality, and operations.
• Proactively identify and implement areas for improvement; develop and maintain productivity standards for all areas of the lab.
• Serve as the point of contact for the AD/QC department, internally and externally, and 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).
• 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 compliance within the area of responsibility.
• Identify best practices and deficiencies, share with peers, and make recommendations for improvement.
• Participate in the development of corrective action plans to guide needed and sustainable improvements.
• Ensure 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 needed changes are made by the effective date of any change(s) in requirements.

Qualifications

• Master's Degree in Biochemistry, Molecular Biology, Cell Biology, or related discipline.
• 7+ years of 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 Council for Harmonisation (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.

Pay

Expected starting pay range: $126,089.60 - $163,924.80. 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.