Cincinnati Children's

Director of Analytical Development – Quality Control

Cincinnati Children's

full-time

Posted on:

Location Type: Office

Location: Burnet • Ohio • United States

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Salary

💰 $126,089 - $163,924 per year

Job Level

Lead

About the role

  • 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

  • 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
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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