Director of Analytical Development and Quality Control

Cincinnati Children's•City of Oneida, NY

About The Position

JOB RESPONSIBILITIES 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. JOB QUALIFICATIONS 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 Primary Location Canal Road Schedule Full time Shift Day (United States of America) Department Applied Gene and Cell Therapy Center Employee Status Regular FTE 1 Weekly Hours 40 Expected Starting Pay Range Annualized pay may vary based on FTE status $126,089.60 - $163,924.80 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. If you want to be the best you can be, you can do it at Cincinnati Children’s. 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 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 Magnet® designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC) We Embrace Innovation—Together. We believe in empowering our teams with the tools that help us work smarter and care better. That’s why we support the responsible use of artificial intelligence. By encouraging innovation, we’re creating space for new ideas, better outcomes, and a stronger future—for all of us. Comprehensive job description provided upon request. Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability Completion of Application You will be asked to fully complete each page of the application to the best of your knowledge. Failure to complete all parts of the application will result in a delay in processing and/or rejection of the application. Need Assistance or Accommodation? Assistance with Application: For assistance or technical support, email [email protected]. Accommodation: We provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. If you require an accommodation in the application process, email [email protected].

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

Nice To Haves

Experience with external Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and testing labs

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 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).
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.