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Product Technical Lead (Technical Manager, Pharmaceutical Sciences) – Mt Vernon - Global Operations

Plats Mount Vernon, Indiana, USA Jobb-id R-072559 Datum inlagd 01/28/2020

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.

Join Astra Zeneca and help us deliver life changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in biopharmaceuticals.

We’re currently looking for a hardworking Product Technical Lead (Technical Manager, Pharmaceutical Sciences) to play a key role in our Manufacturing Sciences and Technology (MS&T) group. You will be responsible for the provision of technical product leadership expertise to a portfolio of oral solid dose (OSD) commercial products.

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
  • This position has no direct reports; however strong stakeholder management and leadership exposure is an important part of the role.

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 AZ’s products for the commercial organization and patients, impacting on both financial and reputational aspects of the business.

Essential for the role:

  • 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
  • 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 best practices 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 for the role:

  • 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

Our site in Southwest Indiana

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 to 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.

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. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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 an excellent fit, please share this posting with them.

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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