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 Associate Director, Laboratory Automation, to join our Analytical Sciences team. You will have experience in laboratory automation technologies and knowledge of cell culture, immunological techniques, multi-parametric flow cytometry, and cell-based functional assays to lead bioassay development and automation. You will manage a lab-based team to deliver new/optimized analytical methods and evaluate technologies. You will improve our laboratory automation using fit-for-purpose technologies to enhance analytical methods and operation workflows together with the assay develop scientists and 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. This role is based in Santa Monica, CA, and reports directly to the Director, Product Analytical Sciences.

What you will do:

Develop automation strategy specifically for immunology cell-based assays and genomic assays.

Implement new technologies and systems to improve assay robustness and scalability

Design protocols, scripting, testing, optimization, and troubleshooting of Hamilton VANTAGE and other liquid handler workstations

Manage strategic, SME, technical, and scientific leadership with a highly technical analytical method development team

Manage projects with internal and external partners including scientists, engineers, data scientists, and IT to design, and improve automation workflows to meet specific user requirements, enhancing data quality and process efficiency

Advance and implement fit-for-scale physical automation for cell-based bioassay/potency (e.g. cytotoxicity, proliferation, cytokine production) and 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

Write, review, and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms

Develop training programs and provide technical support for lab personnel on new automation systems and technologies

Minimum Qualifications:

PhD or 5+ years with MS in biology, bioengineering, bioinformatics or related field with 5+ years of experience in laboratory automation and system implementation

Minimum 1year of people management experience

In-depth experience with operating, developing, and optimizing Hamilton liquid handling platforms is required. Experience with other liquid handling and robotic systems.

Familiarity with several programming languages and several automation software packages (e.g., C++, Python, or Hamilton Venus).

Demonstrate knowledge of Process Development of cellular therapy products and Analytical Method Development within a regulated environment

First-hand experience in the development and qualification of automated biological assays, e.g. immunoassays, multi-parameter flow cytometry, and cell-based potency methods, for release in a QC/regulated environment

Experience with instrument APIs.

Excellent skills in Microsoft Excel (can maintain complex spreadsheets), data analysis, and data visualization software (e.g. Prism, JMP, Tableau, FlowJo, CytEpert, SoftMax Pro)

Demonstrate knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE, and statistical analysis

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $170,879 to $213,599. However, base pay offered may vary depending on multiple individualized factors, including market location, and job-related experience. If hired, the employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program

401(k) plan

Paid vacation and holidays; paid leaves

Health benefits include medical, prescription drug, dental, and vision coverage.

Date Posted

22-Sep-2024

Closing Date

06-Oct-2024Our 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.