Lead Associate, Manufacturing
ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and 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 durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage 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. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
The Lead Associate, Manufacturing will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes supervisory and hands-on participation including scheduling, routine manufacturing operations, non-routine development activities and analysis of complex matters requiring the application of rational problem solving skills and independent judgment. This is a full time position that requires frequent weekend work. The essential duties and responsibilities will include, but are not limited to:
- Lead and perform cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records, including thawing, culturing, and differentiating cells.
- Perform cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records related to the production of ViaCyte’s combination product.
- Perform aseptic fill operations for cell and combination products as part of a fill team.
- Meticulously maintain batch and system records as required throughout the manufacturing process.
- Generate, edit, and optimize manufacturing practices into written SOPs and batch records.
- Prepare media and other reagents according to SOPs or batch records and maintain inventory for these materials.
- Through the strict adherence to manufacturing controls, ensure finished products comply with applicable FDA regulations, cGMPs, and QA/QC and safety requirements.
- Provide supervision and technical training to Manufacturing Associates.
- Collaborate with team members in the identification and implementation of continuous improvement initiatives.
- Design, execute, and report on experiments intended to improve Cell Manufacturing processes.
This position requires BS degree in biology or related field, and a minimum of five years cell culture experience in a development or manufacturing environment are required. Experience in stem cell production and cGMP manufacturing experience is highly preferred. An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable. Hands-on experience working in a pharmaceutical, biotech, or biopharmaceutical manufacturing environment is required, with knowledge of clean room practices being essential. Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing, and expanding cell lines, is required. Production experience with devices, proteins and other biologicals is helpful. Must have demonstrated the 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 highly detail oriented with excellent documentation skills. Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel. Strong verbal and written communication skills are required.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2018-3 and your full name. Send to firstname.lastname@example.org. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.
It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.