Technical Manager - Pharmaceutical Sciences
AstraZeneca AB / Kemistjobb / Södertälje
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hela Sverige 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 currently looking for a talented Technical Manager - Pharmaceutical Sciences to play a key role in our Manufacturing Sciences and Technology (MS&T) group. This is an exciting opportunity to be part of a global organization and you will be responsible for the provision of technical product leadership expertise to a portfolio of oral solid dose (OSD) commercial products. This will require you to apply existing experience in formulation design, dosage form manufacturing, technology transfer, and technical support to regulatory affairs.
This role is based at AstraZeneca's site in Södertälje, Sweden or Macclesfield, UK.
The Technical Manager - Pharmaceutical Sciences 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
In this role you will provide commercial drug product leadership and technical expertise to enable supply strategy, improve product performance and resolve technically challenging issues associated with Oral Solid Dosage manufacturing.
Your accountabilities will include:
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Enable technology transfer through oversight and governance as we create flexibility in AstraZeneca's Supply Chain
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Contribute to the preparation and approval of technically complex responses to regulatory questions as we register our products around the globe
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Influence decisions at manufacturing sites and at suppliers (e.g., in respect to manufacturing equipment capital investments and handle product technical knowledge for a portfolio of products
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Assess the technical capabilities of potential new external and internal manufacturing partners and make supplier selection recommendations
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All these activities have a significant impact on the overall success of Operations by ensuring appropriate manufacturing and testing of AstraZeneca's commercial products. MS&T secures availability of AstraZeneca's products for the commercial organization and patients, impacting on both financial and reputational aspects of the business. Strong stakeholder management and leadership exposure is an important part of the role.
Essential for the role
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Educated to BSc or PhD level preferably in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or related field. Plus 7+ years post degree work experience in Pharmaceutical Operations and/or Pharmaceutical Research & Development
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Ability to perform root cause analysis for problematic or variable manufacturing and analytical methods and identify and deliver improvement opportunities (e.g., using measurement systems analysis tools, design of experiments)
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Extensive experience of technology transfer activities, including required standards and best practices and experience in leading quality/technical risk management activities
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Experience in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
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Understanding of Operations Manufacturing and principles, applications and management of cGMP and strong understanding of statistical principles
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Strong leadership capabilities, including ability to influence globally and work in a team environment and strong communication skills
Desirable for the role
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Working experience in Operations and or Product Development or other science areas (e.g., Formulation Sciences and Physical Sciences)
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Solid understanding in the application of Quality by Design and implementation of new technologies for pharmaceutical manufacture and testing
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Understand process robustness, how to interpret cause and effect and implement control strategies
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Expert in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
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Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2021-03-04ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-03-25
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-101993".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5610426
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