Manager/Sr. Manager, Clinical Supply Chain
Cambridge, MA
CMC /
Hybrid /
Hybrid
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
Cullinan Therapeutics 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
