• Using appropriate risk assessment tools and procedures to make effective decisions on microbiology testing requirements.
• Overseeing outsourced microbiology testing to ensure compliance to regulatory requirements and AZ expectations.
• Delivering financial benefits to AZ through continuous improvement activities with CROs.
• Contributing microbiology inputs to clinical trial and dossier applications and respond to resulting questions from health authorities.
• Leading internal and external project work and other improvement activities.
• May represent MD on Pharmaceutical Project Teams or other R&D teams.
• Ensuring that work is performed in accordance with Pharmaceutical Development or MD global working principles and quality system with appropriate safety (SHE). Maintain knowledge of the regulatory and compliance guidelines as related to the role.
• Assessing, record and report data accurately with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated.
• Engaging customers in development of solutions by applying a broader perspective.
• Preparing documentation and formal reports in accordance with current standards and where appropriate to GMP. Generate CMC documents for regulatory submissions or enquiries.
• Applying technical knowledge to improvement projects and the evaluation of new technology/processes.
• Collaborating with specialist scientific and/or technology networks within Pharmaceutical Development.
• May supervise co-workers and contribute to their training and development by acting as coach/mentor, giving immediate feedback, as appropriate. Develop personal performance by actively seeking feedback and support from peers.

• BSc/MSc in combination with proven experience within the business and industry
• Good knowledge of drug discovery & development
• Possess sufficient understanding and practical experience in the discipline of microbiology and method development
• Have a thorough understanding of principles, applications and management of SHE and cGMP.
• Compliance with all regulatory and AZ requirements relevant to the role, e.g. GMP, AZ Code of Conduct

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