Sr.Manager/Assoc Director, Analytical Development and Quality Control, Applied Gene and Cell Therapy Center

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.

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.