Demo

Senior Scientist, Analytical Sciences

AstraZeneca
AstraZeneca Salary
Santa Monica, CA Full Time
POSTED ON 1/10/2025
AVAILABLE BEFORE 4/2/2025

Are you passionate about being a Senior Scientist specializing in Analytical Sciences? The role involves developing cell-based analytical methods aligned with vector and cellular therapy product critical quality attributes (CQAs) to support process development, product characterization, stability, and release testing of engineered cell therapy products. We have an exciting opportunity for you at AstraZeneca!

Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.

What You’ll Do

We are seeking a collaborative and highly motivated Senior Scientist with expertise in cell culture, immunological techniques, multi-parametric flow cytometry, and cell-based functional assays to lead bioassay development efforts. This individual will grow, manage, and mentor a laboratory-based team to deliver innovative analytical methods and evaluate new analytical technologies. The Senior Scientist will also author and review technical documents, including method development reports, test methods, SOPs, protocols, and CMC sections for regulatory filings. This role is based in Santa Monica, CA, and reports directly to the Director of Product Analytical Sciences.

Essential Functions and Responsibilities :

  • Lead and provide scientific, strategic, and technical leadership to a team specializing in analytical method development.
  • Advance and implement cell-based bioassays (e.g., cytotoxicity, proliferation, cytokine production) and immunophenotyping via multi-parametric flow cytometry, guiding methods from conception through optimization, qualification, and transfer to Quality Control or external partners.
  • Apply Quality by Design (QbD) and Design of Experiment (DOE) approaches to establish robust, phase-appropriate analytical methods meeting ICH guidelines.
  • Collaborate with Process Development to implement and document analytical methods supporting experimental study plans and characterizing novel engineered cell therapy platforms.
  • Partner with Quality teams to draft study protocols, qualification reports, and change controls, occasionally performing routine assays for drug product release and characterization.
  • Author, review, and edit technical reports, SOPs, and regulatory documents, including CMC sections for submissions.
  • Provide mentorship and technical guidance to junior staff, review data, and ensure compliance with cGMP and regulatory standards.
  • Present scientific data and insights at group and departmental meetings, contributing technical expertise in areas of responsibility.
  • Maintain, calibrate, and operate analytical equipment and instrumentation routinely used for assay execution.

Qualifications and Skills :

Education & Experience :

  • Ph.D. in Immunology, Oncology, Cell Biology, or related field with 2 years of experience
  • Master’s degree with 5 years of experience
  • Bachelor’s degree with 7 years of experience
  • Demonstrated expertise in developing and qualifying immunoassays, multi-parametric flow cytometry, and cell-based potency methods in regulated environments.
  • Advanced knowledge of T-cell biology and cell signaling pathways.
  • Proficiency in multi-color flow cytometry (>
  • 10 colors) and data analysis using software such as FlowJo, Prism, JMP, CytExpert, and SoftMax Pro.

  • Strong understanding of QbD principles, including gap analysis, risk assessments, DOE, and statistical methods.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Exceptional critical thinking, troubleshooting, and problem-solving skills.
  • Strong interpersonal, verbal, and written communication skills.
  • Self-motivated and detail-oriented, with the ability to adapt to dynamic responsibilities.
  • Experience thriving in a fast-paced laboratory environment with moderate supervision.
  • Physical Requirements :

  • Regularly required to sit, stand, walk, and communicate verbally (speak and hear).
  • Frequently uses hands and arms for reaching and grasping.
  • Occasionally required to lift and move up to 25 pounds.
  • Specific vision abilities include close vision and the ability to adjust focus.
  • Noise level in the work environment is typically moderate.
  • May involve working with biological and chemical hazards.
  • Travel requirements : up to 5% by car.
  • Why AstraZeneca?

    At AstraZeneca, we seize opportunities for change, recognizing their potential to drive significant advancements. Our mission to deliver life-changing medicines is fueled by ambition—finding those moments that can lead to extraordinary outcomes. Join us on our journey to redefine what a biopharmaceutical company can be. We are pioneering innovative methods and bringing together diverse teams to achieve our goals.

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