Manufacturing Associate, Production Planning & Material Logistics 9/16/2017
San Diego, CA
JOB DESCRIPTIONAPPLY Company Overview
ViaCyte is a leading privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in a durable and retrievable delivery device. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two products in clinical development. The PEC-Direct product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.
Under minimal supervision, the Manufacturing Associate, Production Planning & Material Logistics, will perform a broad range of administrative and support activities to aid in the manufacture of drug substance and drug products under Current Good Manufacturing Practices (cGMP) for use in pre-clinical & clinical studies. This is a full time position. Essential duties will include:
1. Maintain inventories of raw materials used in the manufacturing process, including purchasing, receiving, and organizing materials in a controlled environment.
2. Request and review batch records, system records and materials as required throughout the manufacturing process following good documentation practices.
3. Hands-on participation in routine tasks including those that require clean room gowning and aseptic operations in performance of manufacturing activities according to standard operating procedures (SOPs).
4. Support validation protocols, including studies designed to test and to qualify equipment and processes.
5. Translate manufacturing best practices into written SOPs and batch records; create and revise cGMP documents.