Careers at ViaCyte
ViaCyte employees are part of a professional team focused on creating and commercializing cell therapies for diabetes. ViaCyte provides a positive and collaborative work environment where ideas are welcomed and respected. This dynamic atmosphere has contributed to valuable research discoveries and encourages fun, enthusiastic and active participation in the company’s success. ViaCyte is an equal opportunity employer that offers competitive salaries, benefits and exciting opportunities for career development and growth.
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:
- Maintain inventories of raw materials used in the manufacturing process, including purchasing, receiving, and organizing materials in a controlled environment.
- Request and review batch records, system records and materials as required throughout the manufacturing process following good documentation practices.
- 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).
- Support validation protocols, including studies designed to test and to qualify equipment and processes.
- Translate manufacturing best practices into written SOPs and batch records; create and revise cGMP documents.
- BS degree in a biological science or related discipline. An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.
- Minimum 1 year experience working in a pharmaceutical, biotech, or device manufacturing environment is required, with knowledge of clean room practices desired.
- Experience with GMP level documentation practices, electronic support systems, and working in a clean room environment is preferred. Production experience with devices, proteins, or other biologics is helpful.
- Familiarity with the integration of QA/QC systems in the manufacturing environment is desired.
- Demonstrated ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
- Must be able to use standard Windows operating system and Microsoft Office, including Word and Excel.
- Must be highly detail oriented with excellent documentation and communication skills.
- Must be able to work 1-2 weekend day shifts per month.
The ideal candidate will be technically strong and adept at managing multiple priorities. The ViaCyte team moves at a rapid pace, making resourcefulness and flexibility key contributors to success.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, type Job Code #2017-4 and your full name. Send to email@example.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.