Senior Scientist, Analytical Sciences
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Senior Scientist, Analytical Sciences
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
We are looking for a collaborative and Senior Scientist experienced in cell culture, immunological techniques, multi-parametric flow cytometry, and cell-based functional assays to lead bioassay development. You will manage a lab-based team to deliver new/optimized analytical methods and evaluate new analytical technologies. You will develop cell-based analytical methods aligned with vector and cellular therapy product CQAs to promote process development, product characterization, stability, and release testing of novel engineered cell therapy products. You will author and review method development reports, test methods, and SOPs, protocols, and support the technical review of CMC sections and supporting documents for regulatory filings. 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.
What you will do
As a Senior Scientist, you will execute conjugation, purification, and characterization of Antibody Drug Conjugates (ADCs) and Radioconjugates (RCs). You will innovate and optimize novel conjugation techniques to enhance ADC/RC properties and coordinate and streamline conjugation workflows within a collaborative team environment. Leading and overseeing laboratory operations, including equipment maintenance and adherence to safety protocols, will also be part of your responsibilities.
Essential Skills/Experience
- PManage strategic, SME, technical, and scientific leadership to a technical analytical method development team.
- 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 operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
- Work with Process Development, implementing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms.
- Work with Quality partners to draft study protocols, qualification reports, change controls, and occasionally perform routine assays as a QC personnel for drug product release and characterization.
- Write, review, and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms.
- Provide technical guidance to junior staff, assign tasks, review data, and strengthen regulatory concepts (cGMP)
- Participate in group and department meetings, present scientific data, and provide expertise in areas of responsibility.
- Maintain, calibrate, and operate analytical equipment and instrumentation that is used in the execution of assays.
Minimum Qualifications
- Minimum 7 years with BS/BA; OR a minimum of 5 years with MS/MA; OR a minimum of 2 years with PhD in Immunology, Oncology, Cell Biology, or related field
- Minimum 1 year of people management experience
- 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
- Hands-on experience in implementing assays and analyzing data using multi-color flow cytometry (10+ colors).
- Excellent skills in Microsoft excel (can maintain complex spreadsheets) and data analysis software (e.g. Prism, JMP, FlowJo, CytEpert, SoftMax Pro)
- Demonstrate knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.
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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
