Associate Director, Tech Transfer and External Partnerships (Vaccines)

CSL•Holly Springs, NC

About The Position

Associate Director, Tech Transfer and External Partnerships Position Description Summary: 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.

Requirements

Bachelor’s, Master’s, or PhD in: Chemical / Biochemical / Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field
10+ years of experience in technology transfer, process development, MSAT, or manufacturing
5+ years managerial Experience in Pharmaceutical or Biotechnology industry
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
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-making

Responsibilities

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