Director External Partnerships & Technology Transfer

Director of External Partnerships & Technology Transfer

Position Description Summary

The Director of External Partnerships & Technology Transfer is responsible for establishing and maintaining effective external relationships for the manufacture of gene therapy and recombinant products. The incumbent will work with key CSL functions in selection of external partners that support gene therapy and recombinant team goals to accelerate development and commercialization of products within the assigned portfolio. Key accountabilities include vendor selection, technology transfer, technical dossier writing and ongoing technical support for routine operations at contract development & manufacturing organizations (CDMOs).

Main Responsibilities & Accountabilities

• Identifies external partnering needs for the gene therapy and recombinant portfolio, 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

Qualifications and Experience Requirements

Education

• BSc, MSc or PhD in Life Sciences, Biomedical Sciences, Pharmacy, Biotechnology, Process Engineering or related field required.

Experience

• 10–15+ years experience in process development, method transfer, manufacturing science & technology
• Expertise in adeno-associated viral (AAV) vector gene therapy and recombinant/monoclonal antibody development and manufacturing
• 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

Core Competencies

Technical leadership

• CDMO partnering and technology transfer
• Manufacturing Science & Technology
• Gene therapy and recombinant protein production
• Strategic partnering and external innovation
• Alliance and stakeholder management
• Leadership and cross-functional influence