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Process Development Scientist, Immunology
Full Time
San Francisco, California, United States
Job description
Scismic is supporting the growth of a venture-backed biotech company that is an immuno-oncology focused technology startup based in San Francisco, CA!
The company has had success in raising multiple rounds of financing from some of the top venture capital names in the industry. Their mission is to enhance the performance and safety of cell and gene therapies (CGT) through the design and development of a suite of innovative technologies. Their commercial instruments and AI-driven software enable researchers to discover novel insights into immune and tumor biology. Their product development team is working to translate these insights at patient-scale, through the development of a new cell therapy manufacturing technology. This high growth team will be expanding several folds over the next few years - now is a great time to join!
About the Role:
The company has had success in raising multiple rounds of financing from some of the top venture capital names in the industry. Their mission is to enhance the performance and safety of cell and gene therapies (CGT) through the design and development of a suite of innovative technologies. Their commercial instruments and AI-driven software enable researchers to discover novel insights into immune and tumor biology. Their product development team is working to translate these insights at patient-scale, through the development of a new cell therapy manufacturing technology. This high growth team will be expanding several folds over the next few years - now is a great time to join!
About the Role:
They are looking for an innovative and highly motivated Process Development Scientist with expertise in cell therapy manufacturing to join the team. You will interface across many parts of the company to develop and test novel products used in the cell and gene therapy field. In your role you will assist in developing and testing new manufacturing processes, as well as perform hands-on scientific tasks. Some of your responsibilities include design of experiments, performing experiments, interpreting results, and presenting insights and advice for internal product and process development. You will enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. Ideally, you will also have strong written and verbal communication skill, work well independently and in teams, and are excited about improving processes and technology related to cell and gene therapies
Responsibilities:
- Perform studies to improve the identity, purity, and potency of CAR-T and other cellular products.
- Evaluate scale-up and closed-system processes to ensure reproducibility of drug product.
- Draft documentation (protocols, batch records, reports) to standardize and transfer manufacturing processes.
- Establish tracking and trending analyses of process development.
- Educating mechanical and software engineers with regard to the scientific details of cell therapy manufacturing processes.
- Development and performance of cell therapy manufacturing processes on various types of equipment.
- Responsible for establishing cell therapy manufacturing processes including the following process steps: whole-blood processing, apheresis processing, cell washing, cell isolation, T-cell activation, gene transfer using non-viral and viral methods, cell expansion, cryopreservation and final formulation.
Education:
- BS + 7 years experience, MS + 2 years experience, or Ph.D. + 1 years experience in Industry
Qualifications:
- Expertise in bioreactor cell culture and perfusion technology, including scale-down and scale-up strategies
- Experience with process/tech transfer to clinical and commercial facilities
- Experience with regulatory documentation
- Managerial experience
- Experience with commercial process development, characterization, and validation. GMP manufacturing experience also desirable.
- Experience with high throughput cell culture (e.g. deep-well plate assays or robotics)
- Strength in data science, informatics, and/or automation
- User-Focused - Understands customer pain points, expectations, and needs; regularly brainstorms with team members to develop solutions that help our current and potential users adopt our technologies and expedite research
- Workflow and Project Management - Sets clear, realistic, and time-bound objectives that align to business growth
- Entrepreneurial Spirit - Excels in a fast-paced environment and thrives in dramatically changing the status quo with novel solutions.
Other Desirable Characteristics and Attributes:
- Highly motivated self-starter who can prioritize and take ownership of tasks
- Excited to be “hands-on” in solving product problems
- Must be comfortable in a rapidly growing and evolving start-up environment
- Please note if you are legally authorized to work in the United States in your application