Position Summary The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products. This role is responsible for leading a team of scientists and engineers supporting process development activities from clinical development through commercialization, including BLA and global regulatory submissions. The successful candidate will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and scalable manufacturing processes. Key

Responsibilities

Technical Leadership Lead the late-stage process development for cell therapies within the Process Engineering function, managing multiple development projects Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design, laboratory execution and report authoring activities Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding Team Leadership and Management Build, develop, and manage a high-performing team of process development scientists and engineers Establish project priorities, resource allocation, and departmental objectives Foster a collaborative and innovation-driven culture PPQ & Technology Transfer Support PPQ activities including but not limited to protocol authoring, batch record authoring and planning Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch records Lifecycle Management Lead lifecycle management activities for commercial cell therapy products, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments. Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing commercial readiness. Manufacturing Support & Scientific Deviation Management Serve as the Process Development and Engineering SME for manufacturing operations, providing scientific support for deviations, investigations, atypical events, and process-related issues. Lead root cause analyses, impact assessments, and CAPA development using data-driven and risk-based approaches to ensure product quality, compliance, and uninterrupted manufacturing operations. Regulatory Support Contributes to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements. Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing. Cross‑Functional Collaboration Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment. Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions. Required

Qualifications

Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline with 6+ years of industry experience; or M.S. with 10+ years of relevant experience; or B.S. with 12+ years of relevant experience. Strong technical expertise in cell therapy process development, GMP operations and late‑stage / commercial readiness.

Experience

with late‑stage development, and PPQ for cell therapy processes. Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation. Strong technical writing, data analysis, and problem‑solving skills.

Preferred Qualifications

Experience

with commercial-stage cell therapy or biologics products.

Experience

supporting PPQ, process validation, and post-approval changes. Familiarity with global regulatory requirements and lifecycle management strategies.

Experience

designing and executing DOE and multivariate data analysis for cell therapy processes. Key Competencies Strong team management and talent development experience Excellent cross‑functional communication and collaboration. Ability to operate effectively in fast‑paced, late‑stage development environments. Scientific curiosity, ownership mindset, and willingness to support manufacturing operations. The annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

Benefits

offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. # Hybrid # Cell Therapy Date Posted 10-Aug-2026 Closing Date 30-Aug-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.