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Associate Principal Scientist - Process Analytical Technology (Continuous manufacturing - OSD)

Cheshire East, Mount Vernon, Indiana
Full time
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AstraZeneca UK
Healthcare & medical
10,001+ employees
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Associate Principal Scientist - Process Analytical Technology

Location: Macclesfield (UK), Sodertalje, Gothenburg, Mount Vernon, Wuxi, Durham

Embrace an exciting opportunity to build a long-term, varied career in our fast-paced, growing environment. As an Associate Principal Scientist, you will be a key player in supporting the transformation of AZ commercial manufacturing through continuous direct compression (CDC) for OSDs. Your expertise in PAT, analytical science and technologies will be crucial in providing leadership and ensuring efficient support to internal and external manufacturing sites and testing laboratories located in multiple countries.

Your role will involve providing PAT expertise in close collaboration with PT&D development teams, manufacturing sites and external organisations. You will be responsible for supporting technology transfer and validation of PAT methods and technologies for commercial manufacturing processes. You will also provide expert support to PAT methods and technologies across the commercial lifecycle of drug products, ensuring they remain fit for purpose and in compliance with evolving regulatory requirements. You will help PT&D and manufacturing sites to develop “cutting edge” science applications in PAT to support the implementation and maintenance of enhanced control strategies for drug products.

Essential Skills/Experience:
- MSc or PhD degree in a relevant subject area with proven experience in the use of PAT in the Pharmaceutical or Chemical industries and/or postgraduate experience in Academia with a PAT industrial focus.
- Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of using risk-based approaches for successful delivery.
- Proven track record to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement.
- Effective influencing and prioritization skills to ensure project delivery to deadlines.
- Good communication and stakeholder management skills, and the ability to discuss complex ideas in a simple, easy to understand manner.
- A good understanding of the overall drug development and commercialization process from development, launch and through life cycle management
- A strong understanding of key process analytical technologies, especially NIR, Raman and microwave resonance spectroscopy
- Demonstrated expertise in PAT method development, implementation, optimization and use of Multi-variate data analysis/ Chemometrics (MVDA, PCA, PLS)
- Good understanding of theoretical and experimental approaches to advance the development and application of enhanced control strategies supporting RTR opportunities
- Experience in issue investigation and change assessment from analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc.)
- Knowledge of the principles and management of Safety, Health & Environment (SHE)
- Business acumen and capability to understand business cases in subject matter areas.

Desirable Skills/Experience:
- Work experience in the Pharmaceutical industry in a PAT based role
- Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)
- An understanding of other key analytical techniques such as separation science, NMR and mass spectrometry
- Previous experience and training in Lean, problem solving tools and experience in data analysis and interpretation

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?
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. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices.

Ready to make a positive impact in a team where it means more? Apply now!

Date Posted


Closing Date

12-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.