Associate Principal Scientist – Upstream Process Development (Temporary Maternity Cover)
Job Title
Introduction to role
Accountabilities
- Scientific Leadership across CMC: Own upstream process development work packages across development cycles, maintaining delivery plans, milestones and governance commitments to keep programs on track.
- Mammalian Cell Culture Design: Design, coordinate and interpret CHO-based inoculum, fed-batch and perfusion studies, including media and feed optimization and process intensification, to improve productivity and robustness.
- Laboratory Execution Oversight: Plan and oversee high-throughput and bench-scale bioreactor work using ambr platforms and stirred-tank bioreactors, ensuring scientific rigor, traceable documentation, quality and agreed timelines.
- Data-Driven Optimization: Apply mechanistic understanding, Design of Experiments, multivariate analysis and modelling to identify process drivers, define operating ranges, assess robustness and inform risk-based decisions.
- Product and Process Insight: Integrate growth, viability, metabolism, productivity, product quality and stability data to draw authoritative conclusions and recommend next steps with clear evidence.
- Systems Biology and Modelling Support: Contribute to multi-omics and metabolic modelling initiatives that inform media/feed strategies and process optimization where required.
- Documentation and Governance: Lead preparation, review and approval of experimental plans, SOPs, data records, development reports, process descriptions and CMC documentation suitable for governance and regulatory submissions.
- Cross-Functional Coordination: Represent upstream development on project and CMC teams, communicating progress, risks and recommendations while coordinating timely input from analytical, formulation, manufacturing, quality, regulatory and project management partners.
- Scale-Up and Technology Transfer: Support transfers to internal manufacturing, CMOs and external partners, including authoring transfer packages, troubleshooting and on-the-floor manufacturing support.
- Portfolio and External Management: Manage concurrent internal and external activities, balancing resources and scientific risk to maintain efficient portfolio delivery.
- Mentoring and Matrix Leadership: Provide day-to-day technical guidance, training and coordination to less-experienced colleagues through matrix ways of working; no direct line management.
- Platform and Operational Excellence: Drive laboratory operational excellence, evaluate equipment and technologies, champion digital record keeping and continuous improvement to sustain an effective upstream platform.
- Safety and Compliance: Ensure adherence to Safety, Health and Environment requirements, quality systems, Good Laboratory Science practices and company standards.
- Flexibility in Operations: Support occasional weekend or extended hours for active cell culture or manufacturing campaigns and collaborate across time zones; occasional travel to other sites or partner facilities.
Essential Skills/Experience
- Degree in biochemical engineering, bioprocessing, biotechnology, biology or a related scientific discipline, with substantial relevant industry experience.
- Strong theoretical and practical expertise in mammalian upstream process development, preferably using CHO cell culture.
- Hands-on experience with aseptic cell culture, inoculum expansion and bench-scale or high-throughput bioreactor systems.
- Demonstrated ability to independently plan, execute, analyse and report complex process-development studies.
- Working knowledge of Design of Experiments, statistical analysis and data-driven process optimisation.
- Experience contributing to CMC development, technical reports, process documentation or regulatory-supporting content.
- Ability to lead work through matrix teams, manage concurrent priorities and communicate clear, evidence-based scientific recommendations.
- Understanding of Safety, Health & Environment, quality and compliance requirements in a pharmaceutical R&D laboratory.
Desirable Skills/Experience
- PhD or master's degree in a relevant scientific or engineering discipline.
- Experience across early and later CMC development cycles, process characterisation, scale-up or technology transfer.
- Experience with ambr250 or comparable high-throughput platforms and stirred-tank bioreactors.
- Knowledge of perfusion, process intensification, media or feed development.
- Proficiency with JMP, SIMCA, Design-Expert, Python, MATLAB or comparable analytical tools.
- Experience with systems biology, multi-omics or metabolic modelling.
- Experience working with contract research organisations, contract manufacturing organisations and global project teams.
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.
Why AstraZeneca
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