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!

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 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. 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 experienceMaster’s degree with 5+ years of experienceBachelor’s degree with 7+ years of experienceDemonstrated 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.

Where can I find out more?

Our social media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Competitive remuneration and benefits apply

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We have a generous paid time off program and a comprehensive benefits package.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The annual base pay (or hourly rate of compensation) for this position ranges from $105,875.20 - $158,812.80 USD, either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, 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. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

06-Dec-2024

Closing Date

10-Jan-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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.