GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably.
GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.
Job Summary
The Director of Clinical Supply Chain Operations, reporting to the VP, CMC Process Sciences, will establish and manage efficient, robust clinical supply chains for multiple life saving AAV based drug products.
Responsibilities And Duties
- Responsible for all activities related to managing the supply chain, labeling, inventories, clinical supplies and consumable 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 labelling campaigns with clinical packaging and labelling 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, the Director of Clinical Supply Chain will help manage other critical CMC materials such as master cell banks, regulatory retains and plasmid banks and lots.
**This position is primarily based in University City, Philadelphia (19104), and will follow a hybrid work schedule, combining both on-site and remote work. Occasional travel to our facility located in King of Prussia (19406) may be required.**
Requirements
- Bachelor's, Master's Degree, or PhD in a scientific field of study with 10+ years of relevant experience working in the Biopharmaceutical industry
- Background in Chemistry, Life Sciences is preferred
- 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
- Travel to ensure safe and timely delivery of clinical product will be required
