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 an experienced and experienced professional to join our team as Director, Product Analytical Sciences.
You will manage the leadership and delivery of business-critical projects to support all the analytical aspects related to the late phase of product analytics lifecycle.
As a Director, you will lead a group of scientists for analytical development of multiple cell therapy drug candidates from clinical development through registration. You will represent Analytical Sciences and Development in cross-organizational governance and committees to lead and steer technical and business strategies. You will also lead product characterization, CQA assessment, method optimization, setting scientifically justifiable comparability strategies, specification and control strategies. You will author, review comparability protocols and reports, justification of specifications, and sections of regulatory filings (IND, IMPD), and lead teams to develop business processes and guidelines for coordinated early and late stage analytical development activities to support cell therapy products commercialization, including post-market life cycle management. You will lead and define transfer and comparability studies and characterization strategies to support early and late-phase and post-approval changes. You have expertise in cell therapy flow cytometry and cell-based assays, assay life cycle management and Regulatory requirements. The position is based in Santa Monica, CA and reports to the VP Process Development.
Responsibilities

• Vision in establishing analytical capabilities to support cell therapy products and new modalities.
• Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, and steering cross-organizational agreement within and outside of cell therapy CMC development.
• Team-oriented and experience in several development stages.
• Experience working with flow cytometry, bioassays and lot release/stability functions to ensure collaborations and integrated process and product development.
• Promote assay life cycle from development through qualification, validation, and assay tech transfer internally and externally.
• Author and review analytical CMC sections with solid datasets to evaluate assay characteristics and ensure regulatory compliance.
• Provide technical support for investigations and troubleshooting, identifying causes and actions for methodological issues and important quality events.
• Manage all aspects of analytical projects performed externally at CROs and CDMOs, ensuring assay technical quality and compliance with laboratory operation SOPs.

Education and Experience

• 12 years with BS/BA; 10 years with MS/MA or MBA or PhD with 6 years in Immunology, Oncology, Cell Biology, or related discipline.
• 8 years of leading experience
• Established experience in late stage product characterization, regulatory filing, and response to agency questions.
• Experience in analytical assays and data analysis in different cell-based assays, e.g. multi-color flow cytometry ( 10 colors), live imaging, or ELISA.
• Experience with technical and scientific challenges as applying the novel assays for drug product release from pre-IND to stage products.
• Willingness to occasionally travel for business purposes.

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 $190,000 to $230,000 . 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.