- Independently design, develop, optimize, troubleshoot, and qualify analytical methods to support drug product (DP) release and characterization ensuring technical excellence.
- Evaluate new and innovative technologies for determining drug product potency and product/process impurities.
- Plan and execute routine DP testing activities, including in-process and stability samples, using flow cytometry and ELISA/Ella to support regulatory submissions.
- Lead assay transfer to external partners and training analysts.
- Author, review and own test methods/SOPs, qualification protocols, and technical reports in accordance with regulatory guidelines.
- Document laboratory procedures and experiments with great attention to detail, including Electronic Lab Notebook (ELN) record keeping.
- Analyze data, prepare reports and data packages for communicating with key stakeholders, senior management, and external partners.
- Coordinate tasks across functions, demonstrating prioritization and planning skills.
- Present work to key stakeholders and leadership.
- Provide assistance and mentorship to junior team members.
- Willingness to travel to external partner locations for method‐related support, when necessary.
- Additional duties as assigned.
- Ph.D. in Biology with at least 4+ years of relevant industry experience.
- Strong preference for candidates with experience in immuno-oncology with a focus on engineered T cells and/or other immune cell types.
- Proficiency in a wide range of analytical techniques, including but not limited to multi-parametric flow cytometry, ELISA/MSD, and qPCR/ddPCR.
- Experience in multi-color flow cytometry analyses, including panel design and data analysis is essential.
- Experience in developing cell-based potency assay will be a plus.
- Ability to work in a highly adaptive environment and learn new skills for changing priorities.
- Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance in analytical operations.
- Good understanding of ICH guidelines for assay qualification/validation.
- Basic understanding of method lifecycle management from development to validation and beyond.
- Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.
- Demonstrated resilience, influence, relationship-building, and problem-solving skills in a variety of situations.
- Experience managing, mentoring, and engaging direct reports is a plus.
- 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.
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Senior Scientist, Cell Therapy Analytical Development - San Diego, United States - Turnstone Biologics
Description
We are seeking a highly effective, self-motivated Senior 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 innovating, designing, developing, troubleshooting, and implementing analytical methods. Key responsibilities include independently designing and conducting experiments, analyzing, and interpreting results, and effectively communicating findings in team meetings. Additionally, the role requires collaboration with internal and external partners, including CDMO and CRO. This position is suited for someone who is passionate about cell therapy and thrives in a fast-paced, collaborative environment. The successful candidate will also perform qualification/validation and tech transfer of assays, routine testing of drug product (DP) and in-process samples. 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
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
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.
Senior Scientist, Cell Therapy Analytical Development professionals in San Diego
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Kristine Afanse
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Shreshta Ravi
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