Neogene Therapeutics
Associate Director, Laboratory Automation, Analytical Sciences
Neogene Therapeutics, Santa Monica, California, United States, 90403
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.
Position Summary
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 for 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.
Responsibilities
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
Education and Experience
PhD or 5+ years with MS in biology, bioengineering, bioinformatics or related discipline with 5+ years of experience in laboratory automation and system implementation
1+ years 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 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, job-related experience. If hired, 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 including medical, prescription drug, dental, and vision coverage.
DE&I Statement
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.
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Position Summary
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 for 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.
Responsibilities
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
Education and Experience
PhD or 5+ years with MS in biology, bioengineering, bioinformatics or related discipline with 5+ years of experience in laboratory automation and system implementation
1+ years 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 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, job-related experience. If hired, 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 including medical, prescription drug, dental, and vision coverage.
DE&I Statement
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.
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