Sr.manager/assoc Director, Analytical Development And Quality Control, Applied Gene And Cell Therapy Center

Cincinnati Children's Hospital

Cincinnati, Ohio, USA
$126,089.60 - $163,924.80 py
**
Analytical method development
Gmp qc testing
Regulatory submissions support
** Cincinnati Children's Hospital is seeking a Sr. Manager/Associate Director for Analytical Development and Quality Control in their Applied Gene and Cell Therapy Center. The role requires extensive experience in biopharmaceutical analytical development, leadership capabilities, and a strong understanding of regulatory compliance in the context of advanced therapy products. **

Job Summary

  • Lead and manage the AD/QC function for all cell and gene therapy programs, providing scientific and technical leadership in assay development.
  • Develop, qualify, and transfer analytical methods for identity, potency, purity, safety, and comparability, overseeing GMP QC testing and compliance.
  • Collaborate with external partners and serve as Subject Matter Expert for regulatory interactions, audits, and inspections.

Matching Summary

Match Score: 75

** Cincinnati Children's Hospital is seeking a Sr. Manager/Associate Director for Analytical Development and Quality Control in their Applied Gene and Cell Therapy Center. The role requires extensive experience in biopharmaceutical analytical development, leadership capabilities, and a strong understanding of regulatory compliance in the context of advanced therapy products. **

Salary

$126,089.60 - $163,924.80

Skills & Requirements

Must-have

  • Analytical method development
  • GMP QC testing
  • Regulatory submissions support
  • Cell and gene therapy programs
  • Viral vector and cell assays

Nice-to-have

  • Foster innovation and scientific rigor
  • Enhance interdisciplinary involvement
  • Embrace innovation together

Key Requirements

  • Master's Degree in relevant discipline
  • 7+ years biopharmaceutical analytical development
  • Hands-on analytical technologies experience
  • Strong GMP and ICH guidelines knowledge
  • Proven leadership and team management
  • Experience authoring regulatory CMC sections

Work Rights

Not specified

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