Process Development Scientist
ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
The Process Development (PD) Scientist has a hands-on, independent role, using expert knowledge of process characterization and GMP manufacturing to improve processes and establish specifications for the production of a cell-based therapy designed to treat diabetes. This role provides technical expertise and leadership in the design and execution of experiments for process optimization and scale-up, and is integral to the successful tech transfer of new processes into a GMP manufacturing environment. The ideal candidate will be technically strong and adept at managing multiple priorities. Our business moves at a rapid pace, making resourcefulness and flexibility key contributors to the PD Scientist’s success. This is a full-time position located in the Carmel Ranch area of San Diego and is not eligible for relocation.
Duties and Responsibilities
- Independently design and conduct experiments supporting the characterization and optimization of lab to commercial scale cell manufacturing processes.
- Perform human embryonic stem cell expansion and differentiation into pancreatic endoderm cells using multiple platforms (e.g. multi-layer cell factories, roller bottles, bioreactors, etc.).
- Lead studies for media optimization, and comparability and stability testing for the culture of cells in 2D and 3D. Perform assays including, but not limited to, polymerase chain reaction (PCR), expression profiling, ELISA, and metabolite analysis.
- Maintain detailed and accurate records of experiments performed.
- Perform statistical analyses and use results to determine optimal process parameter ranges, and trend historical data.
- Define, confirm, and establish process requirements for successful transfer of new or enhanced processes, including materials and equipment, to the GMP manufacturing facility.
- Support manufacturing investigations through historical research and experimentation.
- Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide results-driven technical recommendations.
- Draft and/or revise GMP standard operating procedures (SOPs), forms, policies, batch records, proposals, reports and investigations.
- Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to the current manufacturing processes.
- Perform cleaning and maintenance activities required to ensure a contamination-free environment. Support general laboratory and equipment maintenance as required.
A Master’s degree or PhD in Biological Sciences, Bioengineering, or a related field, with 2-5 years of experience in biotechnology is required. An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.
- Extensive aseptic mammalian cell culture experience is required.
- An understanding of GMP biologics manufacturing with an in-depth knowledge in upstream techniques and technologies is required.
- Hands on experience with closed culture systems, and familiarity with the commercially available 2D and 3D cell expansion platforms is preferred.
- Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.
- An eagerness to learn and continuously improve, and a dedication to quality.
- Effective and professional communication skills, written and oral, and aptitude for problem solving and technical writing.
- Ability to work independently and as a team player in a fast-paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives.
- Excellent computer skills, proficient with Microsoft Word, Excel, PowerPoint, and Visio, and working knowledge of JMP or equivalent statistical software.
- Must have a flexible schedule and be able to work some weekends and holidays.
Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.
For submission through BioSpace portal, please attach your resume and cover letter as a Word or PDF file.
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.