Associate Director, Bioanalysis (CPSS Cell Therapy)

AstraZeneca • Gaithersburg, MD

2d • Onsite

About The Position

Associate Director, Bioanalysis (CPSS Cell Therapy) Introduction to role Are you ready to make a significant impact in the field of cell therapy? Join our dynamic team at AstraZeneca as an Associate Director within Clinical Pharmacology and Safety Sciences (CPSS) Cell Therapy team, 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. This position is based in either Santa Monica, CA or Gaithersburg, MD. Accountabilities Lead design and implementation of robust bioanalytical strategies to support clinical assay endpoints, including but not limited to PK/CK/PD, immunogenicity and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline, with special focus on autoimmune and rare diseases. 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 immunology and rare disease portfolio. Provide written and verbal updates to key stakeholders. Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences. Essential Skills/Experience PhD degree in immunology, cell biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy and demonstrated knowledge autoimmune diseases. 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). 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 fitforpurpose analytical requirements, with a record of supporting compliant data packages for IND/CTA/BLA 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. #LI-onsite #CellTherapy When we put unexpected teams in the same room, we unleash 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. At AstraZeneca, we are dedicated to following the science and pioneering new frontiers. Our Oncology team is driven by an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our collaborative research environment unites some of the world's foremost medical centers, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career while making a meaningful impact on millions of lives. Ready to make a difference? Apply now! The annual base salary for this position ranges from $135,058.40 - 202,587.60. 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. Date Posted 11-Feb-2026 Closing Date 12-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Requirements

• PhD degree in immunology, cell biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy and demonstrated knowledge autoimmune diseases.
• 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).
• 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 fitforpurpose analytical requirements, with a record of supporting compliant data packages for IND/CTA/BLA 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 and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline, with special focus on autoimmune and rare diseases.
• 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 immunology and rare disease portfolio.
• Provide written and verbal updates to key stakeholders.
• Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences.

What This Job Offers

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