Senior Scientist, Analytical Sciences
Senior Scientist, Analytical Sciences
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$ 108473 - 162710
1 Vacancy
Job Description
We are looking for a collaborative and technical Senior Scientist experienced in cell culture immunological techniques multi-parametric flow cytometry and cell-based functional assays as part of bioassay development. You will deliver new/optimized analytical methods and evaluate new analytical technologies. You will be responsible to develop cell-based analytical methods aligned with vector and cellular therapy product CQAs to enable process development product characterization stability and release testing of novel engineered cell therapy products. The Senior Scientist will work with the Process Development and Quality Control teams. This role is based in Santa Monica CA and reports directly to the Director Product Analytical Sciences.
You Will:
Provide strategic technical and scientific leadership to a technical analytical method development team assign tasks review data and strengthen regulatory concepts (cGMP).
Advance and implement cell-based bioassay/potency (e.g. cytotoxicity proliferation cytokine production) and immunophenotyping by multi-parametric flow cytometry methods from conception through optimization qualification and method transfer to Quality Control and external partners as part of an analytical control strategy and to support Process Development.
Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
Work with Process Development completing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms and occasionally perform routine assays for characterization.
Work with Quality partners during technology transfers help draft qualification/validation protocols/reports.
Write review and edit accurate technical and development reports CMC sections for regulatory submissions and SOP/maintenance/user requirements for relevant equipment
Participate in group and department meetings present scientific data provide expertise in areas of responsibility.
Maintain calibrate and operate analytical equipment and instrumentation that is used routinely in execution of assays.
You Have:
7 years with BS/BA; 5 years with MS/MA; 2 years with PhD in Immunology Oncology Cell Biology or related discipline
Demonstrate knowledge of Process Development of cellular therapy products and Analytical Method Development within a regulated environment
First-hand experience in development and qualification of immunoassays multi-parameter flow cytometry and cell-based potency methods for release in a QC/regulated environment
Demonstrate advanced knowledge in T cell biology and cell signaling pathways
Excellent skills in Microsoft Excel and Powerpoint and data analysis software (e.g. Prism JMP FlowJo CytEpert SoftMax Pro)
Ability to think critically and demonstrate troubleshooting and problem solving skills.
Willing to accept temporary responsibilities outside of initial job description.
The annual base salary for this position ranges from $108473 to $162710. However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. In addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles).
Our Benefits:
Benefits offered include:
A qualified retirement program 401(k) plan
Paid vacation holidays and paid leaves
Health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
#celltherapy #LI-Onsite
Date Posted
12-Jun-2025Closing Date
25-Jun-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Senior IC
Employment Type
Full-Time
