About the role
Introduction to role:
The Senior Scientist – Upstream Process Development position is a temporary maternity-cover role responsible for the hands-on scientific and technical delivery of upstream mammalian cell culture process development activities supporting AstraZeneca’s biologics pipeline. Working under minimal supervision, the successful candidate will plan, execute, analyze and report laboratory studies for process development, optimization, scale-up and technology transfer, contributing to the delivery of CMC project goals and objectives.
The position resides within Cell Culture Process Design (CCPD) in the Cell Culture and Fermentation Sciences organization within Biopharmaceutical Development. The role holder will work collaboratively with CCPD colleagues and cross-functional CMC partners, including analytical development, formulation, bioprocess engineering, clinical manufacturing, quality, regulatory, supply and project management, as well as external development and manufacturing partners. The role has no direct reports and is not a people-management position; it involves significant hands-on laboratory work, together with day-to-day technical support and coordination of technicians and operators within the team.
Accountabilities:
• Deliver assigned upstream process development activities across CMC development cycles under minimal supervision, working to established methods, project plans and agreed milestones.
• Perform, and contribute to the design and interpretation of, mammalian cell culture studies using predominantly CHO-based systems, including cryopreservation, revival, inoculum expansion, fed-batch and perfusion processes, and media and feed optimization.
• Operate high-throughput and bench-scale bioreactor platforms, including ambr systems, stirred-tank bioreactors (
• Apply Design of Experiments, multivariate analysis and statistical approaches to support the identification of process drivers, operating ranges and process robustness.
• Assess cell growth, viability, metabolism, productivity, product quality and culture stability, analyzing and trending data to draw sound conclusions and propose next steps.
• Prepare and review experimental plans, procedures, data records, development reports and process documents, ensuring timely, high-quality data review and that information is complete, traceable and suitable for CMC and regulatory use.
• Work as a member of cross-functional project and CMC teams, presenting progress, results and risks at team and CMC meetings, and liaising effectively with internal partners, external partners and suppliers.
• Support scale-up and technology transfer into internal GMP facilities and contract manufacturing organizations, including transfer documentation, technical troubleshooting and manufacturing support.
• Plan and coordinate own workload across multiple concurrent work packages, maintaining required quality standards and efficient throughput of work.
• Work closely with technicians and operators, providing day-to-day technical support, training and problem solving; no direct line-management accountability is assigned to this role.
• Take ownership of designated laboratories, equipment or operational systems, and contribute to operational excellence, evaluation of new equipment and techniques, digital record keeping and continuous improvement.
• Maintain scientific expertise through review of current literature and participation in internal and external scientific forums.
• Ensure all work complies with applicable Safety, Health & Environment requirements, quality systems, Good Laboratory Science practices and AstraZeneca standards.
Essential Skills/Experience:
• Degree (BSc/MSc/PhD) in biochemical engineering, bioprocessing, biotechnology, b
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