Director of Analytical Development – Quality Control

Cincinnati Children's

Director of Analytical Development leading Analytical Development and Quality Control at Cincinnati Children’s hospital. Managing biopharmaceutical analytical development and quality control processes for cell and gene therapy programs.

Posted 4/16/2026full-timeBurnet • Ohio • 🇺🇸 United StatesLead💰 $126,089 - $163,924 per yearWebsite

About the role

Key responsibilities & impact

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
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
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

Requirements

What you’ll need

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.

Benefits

Comp & perks

Comprehensive job description provided upon request
Equal Opportunity Employer committed to dignity and respect for all employees, patients, and families
Reasonable accommodations to qualified individuals with disabilities

ATS Keywords

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Hard Skills & Tools

analytical developmentquality controlassay developmentanalytical methodsGMP testingmethod validationqPCRELISAflow cytometryNGS

Soft Skills

leadershipmentoringcommunicationorganizational skillsproject managementcollaborationproblem-solvinginnovationinterdisciplinary involvementrelationship building

Certifications

Master's Degree in BiochemistryMaster's Degree in Molecular BiologyMaster's Degree in Cell Biology