Associate Director, Digital and Data Science - Analytical Sciences

Position Summary:

As the Associate Director of Digital and Data Science in the Analytical Sciences department, you will lead the development, testing, and validation of digital solutions and data science applications aimed at improving analytical methods. You will lead laboratory digitalization programs, driving operational and data automation using fit-for-purpose technologies to transform analytical workflows. Collaborating with assay development scientists, you will ensure process development, product characterization, and establish testing methodologies for novel engineered cell therapy products. Your work will involve close partnerships with the Process Sciences, Analytics, and Technology (PSAT) team, and the Quality team within Cell Therapy Development & Operations (CDTO), to build the requisite technical expertise for implementing activities both internally and with third parties. You will report to Senior Director, Analytical Sciences, and can be performed from either Santa Monica, CA or Gaithersburg, MA location.

Role and Responsibilities:

• Lead digital transformation programs to modernize analytical methods, improving operational efficiency and data management.

• Improve laboratory digitalization by implementing automation technologies that enhance data workflows and increase throughput for analytical processes.

• Collaborate with assay development scientists to ensure process development, product characterization, and testing for engineered cell therapy products.

• Work with the PSAT team and the Quality team within CDTO to gather technical insights and ensure understanding of activities with broader cell therapy development goals.

• Develop and test data science applications, ensuring agreement on our strategic goals for product development and regulatory compliance.

• Oversee the implementation of digital tools and data science techniques to enhance productivity in R&D, in cell therapy applications.

• Lead projects and external partnerships, ensuring teams to meet milestones and deadlines.

• Author and review technical documentation including method development reports, test methods, SOPs, and regulatory filings.

• Provide technical expertise and mentorship to our teams and collaborators.

• Stay current with advancements in digital solutions, automation, and data science applications in the biopharmaceutical industry.

Required Abilities:

• Experience with data cloud platforms (e.g. AWS, Azure, or Snowflake) and SQL skills.

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

• Hands-on experience operating algorithm pipelines, APIs, firmware, and software for liquid handling, analytical, and robotic systems (e.g., Hamilton or similar systems).

• Author and review method development reports, test methods, SOPs, protocols, and technical reviews of CMC sections and supporting documents for regulatory filings.

• Experience with analytical bioassays, ICH guidelines, and cGMP requirements.

• Knowledge of Quality by Design (QbD) approaches to analytical method development, including gap and risk assessments, Design of Experiments (DOE), and statistical analysis.

Education and Experience:

• Degree in bioinformatics, bioengineering, or related field (8+ years with a Master’s; 4+ years with a Ph.D.).

• Minimum of 1 year of project management experience, including leading and implementing projects with external parties and teams.

• Experience with digital and data tools aimed at improving R&D productivity.

• Expertise in machine learning development using multiplex, multi-omics-based profiling data from cell-based assays.

#celltherapy #LI-Onsite

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 to connect, work at pace, and challenge perceptions. That's why we work an average 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 $134,892 to $202,339. 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.

Date Posted

10-Feb-2025

Closing Date

09-Feb-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.