Manufacturing Associate I
Manufacturing Associate I
(Job Code: 2018-12)
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.
As a member of the Cell Manufacturing/Combination Product team, incumbent 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 hands-on participation including materials logistics, assisting in manufacturing operations, and may include non-routine development activities. This is a full time position.
- Assist in manufacturing operations to produce GMP grade PEC-01 and Combination Product to meet corporate goals
- Assist in ensuring that there are sufficient materials available for all production runs or campaigns including media, small molecules, and growth factors.
- Provide hands on support for scale up and development activities as needed based on a demand plan.
- Understand and review applicable GMP documentation including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents.
- Maintain current training status for all applicable activities.
- Assist in maintaining GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification.
- Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements.
Our dynamic workplace is attractive to those who are self-motivated and resourceful. You will be expected to set priorities within your job scope and to meet critical deadlines. Flexibility to handle rapidly changing objectives and timelines is essential.
A college degree in a biological or engineering science is preferred. Minimum of 1 year experience in cell culture-based manufacturing or development operations is preferred.
An equivalent combination of education and industry work experience sufficient to successfully perform the job duties as listed above is acceptable.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2018-12 and your full name. Send to email@example.com. 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.