Technical Manager – Process Engineering/Pharmaceutics

Technical Manager – Process Engineering/Pharmaceutics

Location: Macclesfield – UK

Competitive salary and benefits

Build a long-term career with global knowledge and opportunities

In our fast-paced, growing environment, embrace a great opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.

Technical Operations, Science and Innovation (TOSI) Function:

The function provides the expert technical support for AstraZeneca commercial products. It is a multi-skilled, multi-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 with a background in engineering or pharmaceutics to join our on-market technical capability, working in TOSI.

The role

As a Technical Manager, you will be responsible for leading our engineering and pharmaceutics contribution to the maintenance and optimisation of supply for AstraZeneca commercial parenteral 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 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 processes and wider 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 pharmaceutical processes.

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

  • Provision of training in domain expertise areas.

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

Essential Requirements:

  • A BSc or MEng in an appropriate field (such as chemical engineering or pharmaceutical sciences) with significant and relevant post degree experience in the pharmaceutical industry or equivalent in experience.

  • Experience of supporting the manufacture of sterile products and working with external contract manufacturing organisations.

  • Understanding of a broad range of CMC elements related to commercial product requirements e.g. pharmaceutics, process establishment/optimisation, control of drug products, biopharmaceutics, stability, packaging and commercial manufacturing and validation.

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

Desired Requirements:

  • Specialist in sterile manufacturing with an understanding of a broad range of unit processes e.g. compounding, aseptic fill and finish, sterilisation.

  • Proven experience and training in lean, six sigma and problem-solving tools.

  • 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.

So why AstraZeneca…

Operations is accelerating, fast. Here we have the opportunity to work across our complex, science-led pipeline. It’s what drives us forwards at pace.

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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