Xcellbio is a venture-backed immuno-oncology focused biotechnology company based in San Francisco, CA. Backed by industry-leading venture capital groups, our mission is to enhance the performance and safety of cell and gene therapies through the design and development of innovative technology platforms. Our commercial instruments and AI-driven software enable researchers and clinicians to discover novel insights into immune and tumor biology. Our product development team is working to translate these insights towards translational medicine, through the development of novel cell therapy manufacturing technologies. We are focused specifically on cell therapy processing unit operations related to cell maintenance and expansion, leveraging our unique IP positioning and experience to improve therapeutic potency and persistence during manufacturing processes. Our fun, well-capitalized, and mission-driven team is expanding several-fold in the near-term – now is a great time to join our technology driven organization!
BRIEF DESCRIPTION OF POSITION:
We are looking for an innovative and highly motivated Process Development Scientists with expertise in cell therapy manufacturing to join the team at Xcellbio. 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
EDUCATION AND EXPERIENCE
• BS + 10 years experience, MS + 5-7 years experience, or Ph.D. + 2 years experience in Industry
• 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.
• 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