Senior Specialist, External Manufacturing
Core
Facilitate scheduling, track project milestones, and ensure drug supply delivery for external manufacturing projects of radiopharmaceuticals.
Role type
Senior Specialist, External Manufacturing
Builds
Radiopharmaceutical drug supply for clinical trials
Domain
Oncology / Radiopharmaceuticals / Contract Development Manufacturing
Deliverable
client delivery
Required skills
Project management, GMP compliance knowledge, cross-functional collaboration, financial management, SOP drafting
Preferred skills
CDMO experience, Mandarin language proficiency
Technologies
None stated
Responsibilities
Collaborate with CDMOs and internal teams to ensure on-time drug supply; Plan new material introduction activities within the master manufacturing schedule; Support tech transfer, scale-up, and validation (PPQ/PV); Partner with QA to ensure GMP compliance and audit readiness; Support financial management of invoice approvals.
Seniority
Senior, hands-on specialist