Director, External Partnerships – Technology Transfer

Role Overview

• Identifies external partnering needs for Recombinant IPT, supports Network Strategy make vs buy decisions, associated due diligence activities and vendor selection
• Supports drafting of agreements with external partners e.g. technical service agreements (TSA) product agreements, statements of work (SOW) and direct supply & commercialisation agreements (DCSA)
• Responsible for process and analytical technology transfer oversight between sending and receiving units through to registration
• Provides technical SMEs, including person-in-plant (PIP), for process/analytical development, manufacturing and QC testing at CDMOs through technology transfer into and during routine commercial operations
• Maintains business relationships through development and tech transfer stages transitioning responsibility to CMO Operations post PPQ/registration.
• Ensures that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained
• Ensures key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting
• Evaluates long-term trends, maintains log of loss drivers (e.g. performance, availability and quality losses), identifies improvement levers, and identifies, prioritizes and plans robustness and continuous improvement initiatives
• Maintains capability in CMC Science that interprets developments in CMC guidance, applies relevant standards to CSL projects and diligence activities, ensuring CSL manufacturing processes meet Health Authority expectations.

Requirements

• BSC, Msc or PhD in Life Sciences, Biomedical Sciences, Pharmacy, Biotechnology, Process Engineering or related field required.
• 10–15+ years experience in process development, method transfer, manufacturing science & technology
• Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization
• Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in a technical operations context, in alignment with Enterprise standards
• Experience working within a global matrix organization
• Involvement in cross-functional, multicultural and international teams.

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development