Technical Manager - Process Engineer

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.

We are now offering an exciting opportunity for a talented Technical Manager - Process Engineer to strengthen our Manufacturing Sciences and Technology (MS&T) group. In this role you will be working in a global and cross-functional environment where you will apply your technical expertise in pharmaceutical unit operation equipment for oral solid dose (OSD) commercial products, ensuring the security of supply at manufacturing sites and support delivery of business strategic project in asset transfer and capacity expansion. This role is based at AstraZeneca's site in Södertälje, Sweden, Macclesfield, UK or Shanghai/Wuxi/Taizhou, China.

The Technical Manager - Process Engineer role will work within MS&T, On-market technical function of our Pharmaceutical Technology & Development (PT&D) organisation. The PT&D Organization is responsible for drug product design, development and technical support for drug substances and products throughout the life cycle. MS&T is a multi-skilled organisation based in 7 locations in 5 countries and provide the expert technical support for AstraZeneca commercial oral solid dosage products. MS&T provide technical support and expertise related to product formulation, manufacture, process engineering, statistics, modelling, devices and testing.

What you'll do
The role of the Technical Manager - Process Engineering has the following key responsibilities:

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Provision of technical expertise & leadership to resolve potential equipment related manufacturing issues & complaints impacting supply, including development of suitable corrective and preventive actions in support investigation
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Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion, new equipment etc.) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
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Responsible for the technical support during the transfer of established product manufacturing processes within sites and to external manufacturing partners. Including scale up modelling support.
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Take leadership in developing, maintaining and collaborating with equipment vendors in the support of changes and issues.
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Identify opportunities for manufacturing improvement and lead the impact assessment & support complex technical improvements or major change activities assuring product performance, including provision of support for regulatory file authoring, review, lincense renewals and response to questions.
* Drive standardisation & modernisation of manufacturing equipment across Operations, specific to regulatory expectation, good business practices and quality standards.. This is done by maintaining understanding of both equipment vendor and academic landscape in relation to manufacturing sciences and up-to-date advances in new technologies.

Essential for the role

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Educated to BSc or PhD level in an appropriate discipline such as Chemical Engineering or Mechanical Engineering, with considerable relevant pharmaceutical industry experience
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Have an excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management particularly over a broad range of unit processes and equipment for OSD manufacturing (eg: mixing, drying, compression, roller compaction, coating, physical characterisation awareness, PSD, LOD etc)
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Have experience of a broad range of CMC elements related to commercial product requirements - e.g., process establishment, optimisation and validation, control of drug products, stability, packaging and commercial manufacturing, with good understanding of SHE and cGMP
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Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization, equipment selection, operating principles and validation
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Evidence of excellent communication skills and build excellent relationships with customers


Desirable for the role

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Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
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Have previous experience and training in Lean and six sigma, problem solving tools
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Have experience in data analysis, interpretation, scale up and modelling
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Have strong leadership skills and behaviors with demonstration of being able to work across different functions

What's next!
Are you ready to bring new ideas and fresh thinking to the table and be part of our excellent team - apply today and we'll make it happen together! We welcome your application (including CV and cover letter) no later than March 31, 2021.