Director, External Partnerships – Technology Transfer
Waltham, Illinois, United States of America
Full Time
2 weeks ago
Visa Sponsor
Key skills
pipCommunication
About this role
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.