Associate Director, Lab Automation, Analytical Sciences

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 $256,319. 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) or to receive a retirement contribution (hourly 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 salary (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.

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.

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 authorisation and employment eligibility verification requirements.