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The Associate Director of Technology Transfer & External Partnerships leads the planning and execution of technology transfer activities to external partners, including CDMOs, CMOs, and strategic collaborators. This role ensures successful transfer of processes, analytical methods, and manufacturing knowledge while maintaining quality, compliance, and timelines. The position also manages external relationships to support development, scale-up, and commercial manufacturing across the product lifecycle.
Main Responsibilities & Accountabilities
Technology Transfer Leadership:
- Lead end-to-end technology transfer to external manufacturing and development partners
- Develop and execute tech transfer strategies, plans, and timelines
- Ensure successful transfer of process, analytical, and quality knowledge
- Oversee preparation of transfer documentation, risk assessments, and technical packages
- Monitor execution of engineering, demonstration, and validation batches
External Partner Management:
- Manage relationships with CDMOs, CMOs, and strategic partners
- Serve as primary technical and operational contact for external collaborations
- Evaluate partner technical capabilities, capacity, and compliance status
- Drive alignment on deliverables, timelines, and performance expectations
- Support contract scope definition and governance processes
Cross-Functional Coordination:
- Collaborate with Process Development, MSAT, Manufacturing, Quality, Regulatory, and Supply Chain
- Ensure readiness for clinical and commercial manufacturing at external sites
- Coordinate troubleshooting and issue resolution during transfer and production
- Align internal and external teams on project milestones and risks
Quality & Compliance:
- Ensure compliance with GMP, regulatory, and quality standards during technology transfer
- Support deviations, investigations, CAPA, and change control related to external manufacturing
- Ensure proper documentation and data integrity across partner activities
- Support audits, inspections, and regulatory submissions
Program & Project Management:
- Manage multiple technology transfer projects simultaneously
- Track milestones, risks, budgets, and performance metrics
- Drive continuous improvement in tech transfer processes and best practices
- Support lifecycle management and post-transfer optimization
Leadership & Influence:
- Mentor scientists and engineers involved in tech transfer activities
- Influence cross-functional and external stakeholders
- Contribute to strategic planning for external manufacturing and partnerships
Qualifications & Experience Requirements
- Bachelor’s, Master’s, or PhD in: Chemical / Biochemical / Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field
- 8–12+ years of experience in technology transfer, process development, MSAT, or manufacturing
- Strong experience working with CDMOs/CMOs and external partners
- Solid understanding of GMP, regulatory expectations, and quality systems
- Proven project and stakeholder management experience
- Strong technical understanding of process scale-up and manufacturing
- Global technology transfer and external manufacturing networks
- Process validation and commercial manufacturing support
- Risk management, QbD, and statistical tools (DoE)
- Contract governance and vendor performance management
- Experience supporting regulatory filings and inspections
Key Competencies
- Technical and operational leadership
- External stakeholder and partnership management
- Strategic thinking and execution
- Strong project and risk management
- Cross-functional collaboration and influence
- Quality and compliance mindset
- Problem solving and decision-makin
