Technical Manager – Microbiology

Technical Manager – Microbiology

Location: Macclesfield, Gartuna, West Chester, Mt Vernon

Competitive salary and benefits

Make a meaningful impact on people’s lives with life-changing medicines

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better.

Technical Operations, Science and Innovation (TOSI) Function:

The function provides the expert technical support for AstraZeneca commercial products. It is a multi-skilled, cross-functional organisation that provides technical support and expertise related to drug product formulation, manufacture, process engineering, statistics, modelling, devices and testing. The key activities where we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability.

We are currently recruiting for a Technical Manager who is a subject matter expert in microbiology and aseptic processing to join our on-market technical capability, working in TOSI.

The role

As a Technical Manager, you will be responsible for our microbiology contribution to the maintenance and optimisation of supply for products, meeting cost and quality targets for our customers.

This includes the following responsibilities:

  • Lead, assess impact and support complex technical improvements or change activities, assuring product performance.

  • Own the technical transfer processes throughout major change programmes, delivering key documents.

  • Identify, own and coordinate business function activities across the programme.

  • Provide regular updates to business function partners.

  • Provision of technical expertise to support supply strategy projects (sourcing, asset transfers, capacity expansion, new equipment etc.) and business continuity plans.

  • Improving manufacturing and wider microbiology control strategies to ensure appropriate quality and robustness of commercial products according to current regulatory guidance.

  • Maintain technical knowledge in new manufacturing technologies, including up-to-date advances in new technologies to aid in the improvement of microbiological testing and control.

  • Provide support for regulatory file authoring, review, license renewals, response to questions and development of suitable corrective and preventive actions in investigations.

  • Deliver training in subject matter expertise areas.

  • Identifying, risk assessing and solving potential issues, and acting as an interface between departments.

Essential Requirements:

  • A BSc in Microbiology or closely related Biological Science with significant and relevant post degree experience in microbiology in the pharmaceutical industry or the equivalent in experience.

  • Experience of supporting the microbiological aspects of pharmaceutical manufacture and working with external contract manufacturing organisations.

  • Understanding of a broad range of GMP aspects of microbiological controls and regulations with experience of GMP inspections or audits.

  • Detailed understanding of principles, applications and management of SHE and cGMP.

  • Evidence of excellent communication skills and the ability to build excellent relationships with customers.

Preferred Requirements:

  • Specialist in sterile manufacturing with an understanding of the full suite of microbiological test methods.

  • Strong leadership skills and behaviours that will enable you to work across different functions and challenge the status quo to seek opportunities for business improvement.

  • Experience in the authoring of regulatory submissions and responses to regulatory authorities.

So why AstraZeneca…

Working with medicines that address unmet needs fills us with pride. The potential to make people’s lives better is an incredible feeling. We get to support and positively impact local and global communities, from patients and their families to all of society.

Next steps…

Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available and we hope it’s yours!

Applications are open from 4th to 18th January 2022

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