System One
Location
Worcester, MA | United States
Job description
Title: Associate/Director Supply Chain
Location: Worcester, MA.
Start Date: ASAP!
Duration: 3-6 Month Contract
Hours: Mon-Fri; 8am-4:30pm (ability to WFH 1 day a week and 4 days in office)
Degree:
- BS or BA preferably in a scientific or technical field, manufacturing or business management background
Experience/"Must Haves":
- 10 yrs. exp. in clinical and commercial supply chain management preferably with cell and gene therapy products
- Proven track record of supply chain planning, materials/inventory management, and business process facilitation, including:
* Exp. with supplying clinical trials management of vendors for Cold Chain Storage, Packaging, Tracking and Distribution
* In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements
Duties/Responsibilities:
- Must be able to work independently on multiple projects and able to prioritize work with minimum supervision
- Manage distribution and logistics for multiple clinical programs
- Manage vendor/supplier relationships
- Will be responsible for establishing the site supply chain function and supply chain management of multiple clinical programs working closely with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing and other Clinical Supply Chain personnel
- Create, review and update the supply requirement plans based on strategic elements/study forecasts from department resources and Operations for internal studies and/or programs
- In addition to identifying suppliers; partner with Quality Assurance to maintain the Approved Supplier List
- Develop supply strategies to maximize efficiency, minimize waste while identifying risk and develop mitigation plans
- Communicate and update supply requirements at the project and program level to upper management and ensure seamless coordination of demand and supply
- Achieve operational objectives by providing information and recommendations to strategic plans and budget reviews
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
- Review clinical trial protocol and understand impact on supply
- Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
- Work closely with Clinical Operations to monitor and review enrollment plans and actuals for use in developing the supply requirements plans.
- Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
- Manage national distribution and logistics for multiple clinical programs and commercial products.
Job tags
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