- Responsible for all aspects of clinical supply management including forecasting, packaging, labeling, distribution, inventory monitoring and IRT vendor oversight
- Collaborate with clinical operations to forecast demand
- Work closely with CMC team to develop comprehensive supply plans taking into account anticipated demand and shelf-life limitations
- Manage external CDMO for packaging and labeling operations
- Review and approve pre and post-production documentation of clinical supplies
- Provide logistical support for global shipments of clinical trial material shipments as well as drug substance and drug product as needed.
- Manage Interactive Response Technology (IRT) systems from initial design to implementation and management.
- Manage clinical label design and approval
- Establish clinical supply processes and author associated SOPs
- Bachelor's degree in business administration, supply chain management or related discipline
- 5+ years clinical supply chain experience in pharmaceutical or biotech industry
- Experience virtually managing CMO/CROs
- Experience with CTM planning
- Experience managing IRT vendors
- Solid understanding of cGMPs, clinical operations, and development processes
- Detail-oriented with ability to work in a fast-changing environment
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Manager, Clinical Supply Chain - Burlington, United States - MapLight Therapeutics, Inc.
Description
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You'll Do: We are searching for a highly motivated Manager Clinical Supply Chain. Reporting to the Associate Director, CMC, the desired candidate will be responsible for managing investigational drug supplies for global clinical trials. The candidate will be responsible for all aspects of clinical supply management including forecasting, labeling distribution, monitoring inventory and IRT vendor oversight. This is a fantastic opportunity to join a small team and have a significant impact in addressing unmet patient needs by advancing MapLight's novel pipeline.
Responsibilities:
Qualifications:
MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
