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.
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
The anticipated salary range for this role is $95,000 - $145,000.
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.