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Product Lead (Oral Solid Dosage) MS&T - Mt. Vernon, Indiana

Lieu Mount Vernon, Indiana, États-Unis Job ID R-121912 Date de publication 11/01/2021

Product Lead (Oral Solid Dosage) MS&T - Mt. Vernon, Indiana

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

The Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules, powders and liquids for over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.

The Manufacturing Sciences and Technology (MS&T) team is a multi-skilled organization that provides 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. We are currently looking for an expert Product Lead to play a key role in our 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.

What you’ll do:

  • 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.
  • Enable technology transfer through oversight and governance as we create flexibility in AstraZeneca’s Supply Chain.
  • Contribute to the preparation and approval of technically complex responses to regulatory questions as we register our products around the globe.
  • 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).
  • Assess the technical capabilities of potential new external and internal manufacturing partners and make supplier selection recommendations.

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 key business partner management and leadership exposure is an important part of the role.

Essential for the role:

  • Bachelor’s degree preferably in Pharmaceutical Sciences, Chemical Engineering or related field. Master’s degree or PhD is preferred.
  • 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).
  • Extensive experience of technology transfer activities, including required standards and experience in leading quality/technical risk management activities.
  • Experience in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
  • Understanding of Operations Manufacturing and principles, applications and management of cGMP and strong understanding of statistical principles.
  • Strong leadership capabilities, including ability to influence globally and work in a team environment and strong communication skills.

Desirable requirements

  • Working experience in Operations and or Product Development or other science areas (e.g., Formulation Sciences and Physical Sciences).
  • Solid understanding in the application of Quality by Design and implementation of new technologies for pharmaceutical manufacture and testing.
  • Understand process robustness, how to interpret cause and effect and implement control strategies.
  • Expert in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
  • Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application.

Why AstraZeneca

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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About Operations

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.  COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

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 authorisation and employment eligibility verification requirements.

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