Microbiology Specialist

Role – Scientist, Microbiology

Location – Macclesfield, UK

Duration – 12 months

Inside IR35

The role holder will be working on method development and managing the testing protocols with the PT&D technical teams.

Responsibilities within the teams include:

• 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.

Essential Skills/ Qualifications:

• 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

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.