Key skills
Stakeholder ManagementRisk ManagementStrategic Planning
About this role
Role Overview
- 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
- 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
- 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
- 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
- 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
- Mentor scientists and engineers involved in tech transfer activities
- Influence cross-functional and external stakeholders
- Contribute to strategic planning for external manufacturing and partnerships
Requirements
- Bachelor’s, Master’s, or PhD in: Chemical / Biochemical / Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field
- 7+ 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
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development