Director of Contract Manufacturing Engineering at Thermo Fisher driving cost - out strategy across Asia. Building partnerships and improving operational performance in the manufacturing network.
About the role
- Director of Analytical Development and Quality Control overseeing biopharmaceutical programs for children's health organization. Leading a high-performing AD/QC team with emphasis on innovation and compliance.
Responsibilities
- Plan the annual budget for Analytical Development and Quality Control (AD/QC)
- 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
- 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)
- Sustain a working understanding of regulatory requirements and accreditation standards
- Evaluate area of responsibility for compliance with regulatory and accreditation standards
- Participate in the development of corrective action plans to guide needed and sustainable improvements
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.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Professional development
- Work-life balance
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