Global PAT Lead Development and Industrialisation

Global PAT Lead for Development and Industrialisation, Global Product Development - Make a Meaningful Impact on People's Lives!

Are you ready to take your career to the next level and make a meaningful impact on people's lives with life-changing medicines? Join our Operations team in Durham, NC, as a Principal Scientist and be part of a team where everyone feels a personal connection to the people we impact.

At AstraZeneca, our Operations team has a big ambition: to deliver more medicines to patients, quicker and more affordably. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better.

In Pharmaceutical Technology and Development (PT&D), within Operations, we are the bridge between brilliant science and innovative medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

We are currently looking for a Global PAT Lead for Development and Industrialisation in our Product and Process Control function to strengthen our capabilities in the development and implementation of enhanced control strategies in commercial manufacturing settings. We believe that you have significant scientific and drug project experience and want to strengthen our team by joining us in PT&D.

You will have the chance to set clear directions for the organization in "cutting edge" areas of analytical sciences like in process analytical technology (PAT), support the development and implementation of enhanced control strategies on projects, advise others at a high level, be at the forefront of external interactions and strengthen our presence at commercial manufacturing sites.

What you'll do

As a Global PAT Lead for Development and Industrialisation, you will play a crucial role in driving our strategy in the design, development, and validation of high-quality enhanced control strategies by applying your expert knowledge in the areas of PAT, Chemometrics, advanced process monitoring and control tools, quality systems and global regulations. You will collaborate with cross-functional teams, contribute to regulatory documentation, and lead projects implementing innovative monitoring and control tools to our commercial manufacturing platforms globally, with a strong focus on continuous manufacturing.

You will drive standards and apply Lean in the validation and technical transfer of models and/ or PAT tools supporting product control strategies across Operations. You will also bring a future focussed, innovative mindset to deliver further digitally oriented approaches, data science, predictive modelling and simulation, and artificial intelligence.

Essential for the role:

* Master's degree

* Minimum of 10 years industrial experience (Analytical Chemistry, Pharmaceutical Sciences, or Engineering).

* Demonstrated delivery in PAT, advanced process control or model predictive control in late phase/ early commercial pharmaceutical manufacturing including technology transfer.

* Well versed in ICH guidelines (Q2, Q8, Q9, Q10, Q13 and Q14), Quality by Design principles, development and implementation of enhanced approaches for project/product specific control strategies.

* Experience in authoring relevant sections of NDA/MAA and defence, support of PPQ/CPV, and PAI.

* Expert knowledge of pharmaceutical process equipment/technology for continuous processes

* Demonstrated experience of ensuring compliance with operational requirements (GMP, GAMP, Process Safety, Data integrity, Change Control)

* An understanding of the principles and management of Safety, Health & Environment (SHE)

Desirable for the role:

* PhD Degree

* Experience of working with contract manufacturing organisations to deliver effective PAT solutions.

* Track record of scientific excellence and externally recognized expertise in PAT with a strong and sustained publication record in this area, for example publications, patents, conference presentations.

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