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.

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

GEMMA Biotherapeutics

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