ViaCyte is a leading regenerative medicine company harnessing the latest innovations in science, engineering and regenerative medicine to develop functional cures for chronic diseases. Our proprietary stem cell-based therapy approach has possible application across multiple disease states that can potentially be treated by replacing lost or malfunctioning cells or proteins. The dedicated team at ViaCyte is initially focused on treating Type 1 diabetes with a proprietary platform designed to differentiate stem cells into cells that function like a pancreas by automatically controlling blood glucose levels.
Backed by two decades of research and expertise, we are the first to advance this approach into human clinical trials and show therapeutic effect in patients with the most advanced cell replacement portfolio for Type 1 diabetes. Through partnerships with two world class leaders, CRISPR Therapeutics and W L. Gore & Associates, we are optimizing our cells and therapeutic delivery to create cell replacement therapies for diabetes that do not require immunosuppression and represent a functional cure. With collaboration and patient focus driving our work, our mission is to reduce the relentless burden of disease management, improve health outcomes, and enhance quality of life for people living with chronic diseases.
ViaCyte is headquartered in San Diego, California. For more information, please visit www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.
As a member of the Device Manufacturing team, the Manufacturing Technician shall manufacture clinical and non-clinical grade implantable devices using Good Manufacturing Practices (GMP) while upholding quality regulations and standards. Incumbent shall also perform a multitude of job and manufacturing-related activities needed to sustain the production of products, support the Product Engineering group with development assignments, and communicate with external suppliers. Assigned technical and clerical job tasks are anticipated to be both routine and non-routine with a varying degree of difficulty, and performed with minimal oversight. Department operation is considered moderate-paced in work flow and necessitates adaptation to intermittent work fluctuation and exigency in business needs.
This position is for Full-Time Employee status, day shift schedule. Travel expectation is 0-10%. Flexibility for overtime including weekends may be required upon business needs for increased demand. The incumbent will report at the ViaCyte–General Atomics campus in Torrey Pines, San Diego. The Work-From-Home (WFH) occupational setting is not applicable to this position as manufacturing operative duties must be performed onsite. Conversely, administrative and other work projects not requiring the use of a cleanroom or ancillary laboratory areas may be performed remotely offsite if applicable.
Essential Duties & Responsibilities:
- Manufacture, assemble and test device subassemblies and device products in a non-aseptic clean room environment according to manufacturing a Standard Operating Procedure (SOP) and other controlled documentation.
- Perform an assortment of manufacturing activities in a production line custom by converting raw materials into finished goods, and conducting qualitative & quantitative inspections per design specification. Perform various quality control inspections on raw materials, in-process components, and finished products per controlled documentation. Perform packaging and distribution on in-process and finished products.
- Support the execution of product design verification testing, assist with equipment qualification protocols, recording data results, and collaborate with the Product Engineering group to support Device Manufacturing related requests.
- Follow and execute production batch records via established GMP manufacturing processes.
- Perform scheduled preventative maintenance on manufacturing equipment. Aid coordination of controlled asset equipment calibration with vendors, Engineering and Document Control. Execute equipment status changes forms.
- Liaise with Materials Management and Quality Control departments to schedule inventory-controlled material pulls through prepared inventory requisitions. Perform incoming material receiving duties per part specification, and assist with orderliness of the Device Manufacturing storage warehouse and inventory supermarket.
- Support composition and revision to SOPs, batch records and other controlled documents applicable to Device Manufacturing, as needed.
- Aid in identifying and implementing continuous improvements to the Device Manufacturing department through lean manufacturing strategies where applicable.
- A high school diploma is required. An Associate degree or higher is preferred. Minimum of 5 years work experience with at least 2 years in medical device manufacturing or in a similar production environment is required. Must be able to compose and communicate in English.
- Experience with operating manual and semi-automated manufacturing equipment using gross and fine motor skills are required. Equipment familiarity includes (but not limited to): stereo microscopes, heat staking, decay/leak testing, adhesive bonding, packaging, and industrial laser application.
- Comprehension and application of GMP documentation habits and workmanship in a manufacturing environment according to SOPs or directed work instructions. Upholding Good Documentation Practice (GDP) for recording written entries into batch records and inspection forms.
- Ability to identify, distinguish and judge product defects and process anomalies which can occur during manufacturing. Ability to read and follow product drawing schematics for dimensional, visual and functional testing instructions per specification.
- Ability to follow, train, review and revise manufacturing SOPs and batch records through change control management systems. ISO class cleanroom operating experience and gowning procedures for non-aseptic environments is required.
- Excellent verbal and written communication skills are required. Must be able to communicate effectively across multiple audiences in a professional demeanor.
- Ability to adapt and handle multiple and simultaneous assigned tasks in a flexible manufacturing system setting with limited management.
- Proficient in basic Microsoft Office software applications is required; working knowledge in advanced Microsoft Office software is a plus. Proficient in personal electronic-based utilities (cell phone, computer) and appropriately navigating through them for communication and productivity.
- Knowledge of quality systems for medical devices (ISO 13485 and FDA QSR) a plus.
- Familiarity and use of Kanban, Kaizen, 5S and other lean manufacturing principles is highly desirable.
ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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.