- Perform routine analytical testing to characterize TCR-T cell products or manufacturing processes using digital PCR assays, flow cytometry, cell-based assays, or ELISAs.
- Support lot release testing for TCR-T cell products if required.
- Assist in lot release or stability testing of raw materials using plate-based assays or other immunoassays.
- Participate in the drafting and revision of test methods, SOPs, and/or other relevant documents.
- Contribute to tracking assay results and test method performance parameters.
- Engage in assay qualification activities when necessary.
- Help in the daily operation of analytical laboratories, including equipment management and reagent inventory.
- Contribute to building result datasets for data visualization.
- Successfully complete projects, testing, and tasks as assigned and report results within deadlines.
- Support cross-functional projects involving process development, manufacturing, quality control, and quality assurance teams.
- Hands-on experience in performing qPCR (or d(d)PCR), flow cytometry-based assays, and/or cell-based assays is necessary.
- Experience in characterizing CAR-T, TCR-T, or other immune cell-based therapy products is highly valued.
- Proficiency in multi-color flow cytometers and analysis software (e.g., FACSDiva or FlowJo) is highly desired.
- Proficient in molecular biology assays (e.g., qPCR or d(d)PCR) is preferred.
- Detail-oriented in technical assay execution and data analysis.
- Familiarity with data visualization software (e.g., Tableau or Spotfire) is a plus.
- Strong verbal, written, and presentation skills for scientific studies and projects are desirable.
- Enjoy working in a fast-paced, dynamic team and company environment and capable of adjusting workload based on changing priorities.
- BS degree in Biochemistry, Cell Biology, or a related discipline with 4-6 years of relevant experience, or a Master's degree in Immunology, Molecular Biology, or a related field with 2-4 years of relevant experience.
- Highly desirable to have experience in the field of Cell therapy.
- Experience in executing cell-based assays, flow cytometry-based assays, or digital PCR-based assays, and assisting in troubleshooting the mentioned assays.
- Background working in a regulated environment (e.g., GMP, GLP, or CLIA) is beneficial.
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Neogene Therapeutics Santa Monica, United StatesThe Senior Associate, Analytical Development will be responsible for the execution of routine testing, including but not limited to flow cytometry assay, cell-based cytotoxicity assay, or PCR-based assay, to characterize or release engineered TCR-T cell drug product. Additionally ...
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Senior Associate, Analytical Development
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Neogene Therapeutics Santa Monica, United StatesThe Senior Associate, Analytical Development will be responsible for the execution of routine testing, including but not limited to flow cytometry assay, cell-based cytotoxicity assay, or PCR-based assay, to characterize or release engineered TCR-T cell drug product. Additionally ...
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Senior Associate, Analytical Development - Santa Monica, United States - Neogene Therapeutics
Description
Senior Associate, Analytical Development at AstraZeneca
The Senior Associate in charge of Analytical Development will be responsible for carrying out regular testing, such as flow cytometry assays, cell-based cytotoxicity assays, or PCR-based assays, to characterize or approve engineered TCR-T cell drug products. Furthermore, this position may involve contributing to the day-to-day operational tasks of the Analytical Development team based in Santa Monica, CA, reporting directly to the Senior Scientist for Analytical Development.
Required Skills/Abilities
Education and Experience
About AstraZeneca
AstraZeneca is committed to diversity and equality of opportunity. They aim to construct an inclusive and diverse team comprising individuals from varied backgrounds with a wide range of perspectives and top-notch skills. Their belief is that the more inclusive their team is, the better their work will be. AstraZeneca encourages applications from all qualified candidates, irrespective of their characteristics, to join their team. They adhere to all pertinent laws and regulations related to non-discrimination in employment, recruitment, work authorization, and employment eligibility verification requirements.
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