Manager/Sr. Manager, Clinical Supply Chain

3 weeks ago

Cambridge, United States Cullinan Therapeutics Full time
Summary:

Cullinan Oncology is seeking an experienced Sr. Manager reporting to the Senior Director of Supply Chain, you will support the planning, creation, implementation, build, and optimization of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Cullinan's clinical programs.

Position Responsibilities:
    • Support the development and implementation of global Clinical Supply Chain strategies for Cullinan's programs
    • Manage global inventories, shipping, and third-party manufacturers / logistics providers for your assigned program
    • Daily management Interactive Response Technologies (IRT) and supporting systems.
    • Support of packaging, labeling, and distribution activities at preferred vendors
    • Generate and manage clinical IP labels
    • Experience developing clinical supply strategy for early to late-stage clinical development programs.
    • Excellent project management, organizational and communication skills.
    • Experience in working with clinical contract packaging and labeling organizations.
    • Experience with clinical trial start-up and IRT systems.
    • Understanding of regulatory requirements for US and ex-US clinical supply distribution and labeling.
    • Understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
    • Identify and Escalate Supply Chain risks as needed and offer solutions.
    • Support creation of Program Pharmacy Manuals.
    • Develop and support creation of supply plans for drug substance and drug product across supply chain based on Clinical, Development, Partner, and Commercial demands.
    • Experience working with Eu Qualified Persons (QP
Candidate Requirements:
    • BS/MS degree
    • Minimum 4-5 years early to late phase clinical supply chain management
    • Thorough knowledge of Good Manufacturing Practices (GMP)
    • Experience working within and collaborating effectively as a member of a cross-functional team.
    • Inventory management and third-party logistics oversight experience
    • Experience generating and managing forecasts.
    • Global shipping and customs experience
    • Solid experience developing clinical labels.
    • Experience developing IRT specifications.
    • Hands-on experience and troubleshooting proficiency with QMS and purchasing systems.
    • Excellent project management skills

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