Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies for the treatment of solid tumors. Bulk tumor infiltrating lymphocytes (TILs) have demonstrated promising clinical activity in solid tumor cancers, confirming a foundation of biology to significantly improve upon and enhance. Turnstone is advancing the next generation of TIL cell therapy – an innovative Selected TIL platform designed to use harvested TILs from patient’s unique tumors to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. Turnstone anticipates dosing patients in 2022 for the first product in this pipeline, TIDAL-01, with a significant pipeline of TIDAL-02 and TIDAL-03 to quickly follow. Consistent with Turnstone’s history of being fearless in taking on modality complexity to access best-in-class therapeutic biology for solid tumors, Turnstone has also developed a proprietary vaccinia live virus platform, referred to as our RIVAL platform. RIVAL is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The Company has an actively enrolling Phase 1/2a clinical trial in solid tumors (RAPTOR) with RIVAL-01, and is developing RIVAL-02 to work in concert with the TIDAL platform.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected. Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’. If you are a passionate person, and our science excites you – this opportunity may be for you.
The Scientist/Senior Scientist will be key contributor to analytical development for the cell therapy programs at Turnstone Biologics. Primary responsibilities include development of novel potency assays, development and optimization of existing flow cytometry characterization methods and analytical support for internal process development and research on Turnstone’s portfolio of next generation cell therapy technology. The candidate will also be responsible for supporting analytical technology transfer to contract manufacturers and sustaining support for analytical testing during GMP manufacturing. The role requires expertise in flow cytometry and prior experience applying rigorous analytical development principles to the design of cell-based functional assays. Essential to the role will be collaboration with cross functional stakeholders. The Scientist/Senior Scientist will collaborate with research, process development, manufacturing, quality and regulatory teams to ensure analytical methods are effectively designed, characterized, controlled, documented and compliant. The position reports to the Associate Director, Analytical Development, and will be located in San Diego, CA.
Summary of Key Responsibilities
· Develop and execute new and existing analytical methods in support of cell therapy product development
· Collaborate with research and process development to design and develop robust cell-based potency assays
· Troubleshoot and optimize existing flow cytometry characterization panels to improve robustness and test method workflows
· Design and develop expanded flow cytometry panels for improved phenotypic characterization
· Design and develop high dimensional flow cytometry panels for deep immunophenotyping using conventional and spectral flow cytometry
· Develop cutting-edge analytics and data visualization workflows for both flow cytometry and RNA/DNA sequencing data, ensuring results are both reproducible and auditable
· Maintain detailed experimental records in lab notebooks, analyze and interpret data, and present data to cross functional teams in research, process development, manufacturing and quality
· Perform previously established methods in support of process development, product release and stability, and product characterization
· Support development of analytical methods to quantify and characterize genetic stability and detect on and off target genetic editing of T cells
· Support instrument and reagent standardization, and instrument performance optimization for analytical methods
· Support analytical technology transfer and method qualification at contract manufacturing organizations
· Provide analytical support to the internal manufacturing and QC teams during deviation and OOS investigations
· Author protocols, reports and SOPs to document development studies and ensure method standardization
· Utilize appropriate statistical methods to design studies and analyze development data
· Contribute to analytical sections of regulatory submissions and related information requests
· BS in cell biology, immunology, biochemistry, molecular biology, or related discipline with at least 5 years analytical development experience. PhD preferred.
· Demonstrated ability to collaborate with cross functional stakeholders in the design and execution of the analytical method development across multiple platforms
· Technical expertise in multi-color flow cytometry
· Prior experience with qPCR, NGS, cell counting and ELISA
· Prior experience in design and development of cell-based functional assays preferred
· Prior experience in assay standardization and qualification for cell therapy
· Prior experience with assay validation preferred
· Prior experience in analytical technology transfer to internal or contract manufacturing teams preferred
· Prior experience with statistical analysis of data, including use of JMP software
· Working knowledge of cGMPs and relevant regulatory guidelines, with experience in authorship of regulatory submissions preferred
· Familiarity with ICH and USP guidelines for analytical method development preferred
· Prior experience working across multiple projects in a fast paced, hands-on environment
· Exceptional written and oral communication skills
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.