Scientist, Cell Therapy Analytical Development
4 weeks ago
We are seeking a highly effective, self-motivated Scientist to join our Analytical Development team at Turnstone Biologics. In this role, you will contribute to the advancement of our cell therapy programs, particularly in developing next-generation T-cell therapies for solid tumors. The ideal candidate will be responsible for developing, qualifying, and implementing analytical methods for drug product (DP) and in-process sample characterization with minimal guidance. Key responsibilities include designing and conducting experiments, analyzing, and interpreting results, and communicating findings in team meetings. Additionally, the role requires collaboration with internal and external partners, including CDMO and CRO. The position is an onsite, lab-based role in La Jolla, CA, with responsibilities as an individual contributor, reporting to the Director of Analytical Development.
KEY RESPONSIBILITIES
- Contribute to the development, optimization, qualification, and transfer of analytical assays, including potency and phenotypic profiling for both lot release and characterization of cell therapy products.
- Design and execute assays and characterization studies to interrogate immune cell biology and function with minimal assistance.
- Plan, coordinate, and execute analytical testing using multi-parametric flow cytometry, ELISA/Ella/MSD, and molecular methods.
- Collaborate cross-functionally and support routine Process Development (PD) sample testing and other internal/external studies supporting regulatory submission.
- Document laboratory procedures and experiments with great attention to detail, including Electronic Lab Notebook (ELN) record keeping.
- Support method transfer to partners at external contract manufacturing organizations, including compilation of documentation (protocols, test methods, reports).
- Develop, revise, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols / reports.
- Analyze data, prepare reports and data packages for communicating with key stakeholders, senior management, and external partners.
- Willingness to travel to external partner locations for method‑related support, when necessary.
- Additional duties as assigned.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
- MS with 4+ years OR PhD in Biology with 1+ years of Analytical Development experience.
- Hands-on experience with flow cytometry and ELISA-based assay development optimization, and troubleshooting is required.
- Experience with cell-based potency assessment and functional characterization of drug products is desired.
- Strong technical acumen, with a keen eye for detail in data analysis and record-keeping skills.
- Basic understanding of ICH guidelines for assay qualification/validation.
- Experience with data analysis such as GraphPad Prism, FlowJo and JMP.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Demonstrated ability to manage multiple tasks/projects with demanding timelines.
- Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
- Occasional travel to support cross-functional workshops or strategy/planning activities.
COMPENSATION/BENEFITS
At Turnstone, we prioritize the well-being and success of our team. Join us and enjoy a competitive compensation package, including a base salary and performance-based bonuses. Our comprehensive benefits include:
Healthcare Coverage: Medical, dental, and vision insurance for you and your dependents.
Retirement Planning: 401(k) plan with employer contributions.
Time Off: Generous paid time off, including vacation, sick leave, and holidays.
Workplace Flexibility: Flexible schedules and remote work options.
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