Senior Supply Planner managing end - to - end supply chain including demand, production, and inventory at Knauf Egypt. Collaborating with teams to optimize planning and ensure material availability in Cairo Office.
About the role
- Director of Clinical Supply Chain Operations at GEMMABio managing supply chains for AAV based drug products. Involves planning, execution, and coordination with various internal and external stakeholders.
Responsibilities
- Responsible for all activities related to managing the supply chain, labeling, inventories, clinical supplies and consumables for Gene Therapy clinical candidates
- Responsible for domestic and international clinical and commercial distribution from Bulk Drug Product to Patient delivery.
- Plan and execute packaging and labeling campaigns with clinical packaging and labeling vendors for US, EU and ROW clinical supply and release to meet timely delivery of clinical products to clinical sites in US and ex-US.
- Provide technical, project management support to the internal clinical operations group and external clinical CRO and coordinate release and product supply and expiry.
- Oversee the external relationships with external vendors and the associated master service agreements and contracts.
- Maintain active inventory of clinical material and supplies and coordinate the supply of the materials from manufacturers to clinical sites or depots.
- Coordinate with internal functions such as Quality Assurance, Clinical Operations, Regulatory Affairs, Project Management, Legal (contracts), and CMC functions.
- In addition to clinical supply chain, help manage other critical CMC materials such as master cell banks, regulatory retains and plasmid banks and lots.
Requirements
- Bachelor, Master's degree, or PhD in a scientific field of study
- 7-10 years of relevant experience working in the Biopharmaceutical industry
- Background in Chemistry, Life Sciences is preferred along with a Masters Degree.
- Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution
- Proven track record of supply chain planning, materials/inventory management, and business process facilitation
- Experience in clinical and/or commercial supply chain management of gene therapy products is preferred
- In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary environment
Benefits
- Flexible work arrangements
- Occasional travel to our facility
Job title
Job type
Experience level
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Not specified
Degree requirement
Tech skills
Location requirements
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