Associate Director, Bioanalysis (Cell Therapy)

AstraZeneca • Santa Monica, CA

4d • Hybrid

About The Position

Join our dynamic team at AstraZeneca as an Associate Director within the Cell Therapy Enterprise, where you will lead the design and implementation of robust bioanalytical strategies to support clinical assay endpoints. Your expertise will be crucial in advancing our cell therapy pipeline and transforming the lives of patients. We are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society. Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Requirements

• PhD degree in immunology, cellular and/or tumor biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy
• Demonstrated experience managing/directing analysis of clinical biospecimens to support clinical trials.
• Proven experience in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments
• Able to evaluate and interpret complex data sets using analysis and visualization software (i.e. Cytobank/OMIQ/FCS Express, Tableau/Spotfire/JMP), experience with AI tools is a plus.
• Work cross-functionally and collaboratively with project stakeholders.
• Deep understanding of cell therapy biology and up to date with latest analytical methods applicable to characterization of cell therapy products and mechanism of action.
• Understanding of global regulatory expectations and analytical requirements to support regulatory filings.
• Experience managing assay development teams, overseeing tech transfers, scientific quality and study conduct internally and at CROs.
• Ability to interpret complex datasets and exceptional ability to communicate results verbally, in writing and in presentations adapting to different audiences as required.
• Ability to prioritize multiple projects and task concurrently in a fast-paced environment.

Responsibilities

• Lead design and implementation of robust bioanalytical strategies to support clinical assay endpoints, including but not limited to PK/CK/PD, immunogenicity (humoral, cellular, viral) and biomarkers related to cell and gene products to support the AstraZeneca cell therapy pipeline (CAR/TCR/in vivo).
• Identify, evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data.
• Lead and oversee assay development, qualification/validation and tech transfer (when appropriate) of cell therapy-related bioassays at CROs or using internal capabilities.
• Interpret and integrate complex datasets within programs and across the cell therapy portfolio.
• Provide written and verbal updates to key stakeholders.
• Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree