CSL

Director, External Partnerships – Technology Transfer

CSL

full-time

Posted on:

Location Type: Office

Location: Waltham • Illinois • Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
process developmentmethod transfermanufacturing sciencetechnology transferanalytical technology transferprocess monitoringcontinuous improvementCMC Sciencetechnical service agreementscommercialization agreements
Soft Skills
communication skillsconflict managementinfluencing skillsorganizational skillsproject managementteam collaborationstakeholder engagementcross-functional teamworkmulticultural awarenessleadership
Certifications
BScMScPhD