The Company - AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical company where we not only focus on the discovery, development and delivery of life-saving medicines to our patients, but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great place to work and have a culture that inspires innovation and collaboration. We empower our colleagues to express diverse perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity!
We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do ground-breaking, unique work that has big impact on science and medicine.
The Role
Pharmaceutical Technology and Development (PT&D) are the bridge which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines, from supplies for use in early toxicology studies and clinical trials, to developing the technology to ensure drugs can be scaled up for commercial manufacture.
An exciting opportunity has now arisen for a Scientist/ Senior Scientist in our microbiology team in Global Product Development at our Macclesfield site. This role will be working on method development and managing the testing protocols with the PT&D technical teams and global Microbiology technology projects. Other responsibilities will include;-
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Using appropriate risk assessment tools and procedures to make effective decisions on microbiology testing requirements.
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Overseeing outsourced microbiology testing to ensure compliance to regulatory requirements and AZ expectations.
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Delivering financial benefits to AZ through continuous improvement activities with CROs.
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Contributing microbiology inputs to clinical trial and dossier applications and respond to resulting questions from health authorities.
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Leading internal and external project work and other improvement activities.
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May represent MD on Pharmaceutical Project Teams or other R&D teams.
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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.
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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.
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Engaging customers in development of solutions by applying a broader perspective.
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Preparing documentation and formal reports in accordance with current standards and where appropriate to GMP. Generate CMC documents for regulatory submissions or enquiries.
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Applying technical knowledge to improvement projects and the evaluation of new technology/processes.
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Collaborating with specialist scientific and/or technology networks within Pharmaceutical Development.
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May oversee 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.
- The ability to problem solve and develop innovative solutions
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Pro-activity and enthusiasm for continuous improvement
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Concern for quality standards
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Delivery and customer focus
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PhD or a BSc/MSc in combination with validated experience within the business and industry
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Good knowledge of drug discovery & development
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Possess sufficient understanding and practical experience in the discipline of microbiology and method development
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Experience of the microbiological aspects of aseptic manufacturing.
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Have a thorough understanding of principles, applications and management of SHE and cGMP.
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Compliance with all regulatory and AZ requirements relevant to the role, e.g. GMP, AZ Code of Conduct
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Evidence of good communication skills and strong operational relationships with customers.
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
What's next?
Please apply with your current CV and a covering letter which presents your key areas of strength and why you should be considered for the role.