- 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.
- 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.
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Scientist, Analytical Development
2 weeks ago
Turnstone Biologics Corp. San Diego, United StatesAt 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 ...
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Vertex Pharmaceuticals San Diego, United States**Job Description**: · The Analytical Development Research Associate performs a variety of well-defined support functions and · performs analytical procedures as outlined by their supervisor. The Analytical Development Research · Associate will support the goals and timelines for ...
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BCforward San Diego, CA, United States Full timeInformation Developer BCforward is currently seeking a highly motivated Information Developer for an opportunity in San Diego, CA · Position Title: Information Developer · Location: San Diego, CA 92127 · Anticipated Start Date: · Please note this is the target date and is subje ...
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Oracle Analytics Developer
2 weeks ago
Gardner Resources Consulting, LLC San Diego, United StatesMust Haves · 10+ years of overall IT Experience · Experience with Oracle OAC (cloud) & OAS (server-side) - Ideally someone with both. · Google Big Query or Google Cloud (GC) expertise. · Intangibles: Typical that we look for; leadership qualities, proactive, collaborative, poli ...
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Associate Director, Analytical Development
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Capstan Therapeutics San Diego, United StatesAbout Capstan Therapeutics · Capstan Therapeutics, Inc. is a privately held biotechnology company dedicated to advancing in vivo cell reprogramming. The core platform technology comprises proprietary targeted lipid nanoparticles (tLNPs) that are composed of LNPs conjugated with a ...
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Capstan Therapeutics San Diego, United StatesAbout Capstan Therapeutics · Capstan Therapeutics, Inc. is a privately held biotechnology company dedicated to advancing in vivo cell reprogramming. The core platform technology comprises proprietary targeted lipid nanoparticles (tLNPs) that are composed of LNPs conjugated with ...
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Reporting & Advanced Analytics developer
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ATR International San Diego, United StatesWe are seeking a Reporting and Advanced Analytics developer for a very important client. · This position is for a Reporting and Advanced Analytics developer with a focus on Client Supply Chain projects and a potential for engagements with other business units. · •Candidate will ...
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Analytical Development Research Associate
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Vertex Pharmaceuticals San Diego, United StatesJob Description: · The Analytical Development Senior Research Associate independently performs complex experimental procedures designed through collaboration with their supervisor. Works collaboratively with the analytical team providing technical support to achieve program goal ...
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Crinetics Pharmaceuticals San Diego, United StatesAssociate Director, CMC-Analytical Development · Categories: CMC (MFG) · Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of ...
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Associate Director Analytical Method Development
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Proven Recruiting San Diego, United StatesAssociate Director, Analytical Development If culture and mentorship are your priorities youve found your match. This pioneer company in Biotech is looking to support and promote a talented Manager, Analytical Development who will assist in advancing cutting edge immunotherapy an ...
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Associate Director Analytical Method Development
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Neurocrine Biosciences Inc. San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Turnstone Biologics San Diego, United StatesWe 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 so ...
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Kumquat Biosciences San Diego, United States: · Location: San Diego, CA 92121 · Position type: Full time · Job Code: KB-CMC-XX · Required education: Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: Analytical chemistry or related field · Description · Kumquat Biosciences is committed to the discove ...
Scientist, Cell Therapy Analytical Development - San Diego, United States - Turnstone Biologics
Description
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
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.
Scientist, Cell Therapy Analytical Development professionals in San Diego
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Shreshta Ravi
Global Talent Analytics Director
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Kristine Afanse
Business Development