Principal Scientist in Process Analytical Technology
AstraZeneca

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 Research Triangle Park, 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 affordable. 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 Principal Scientist in Process Analytical Technology in our Product and Process Control unit to strengthen our capabilities in the development and implementation of enhanced control strategies to our late-phase portfolio. 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 in North America.

What you'll do:

• 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 PAT, Chemometrics, advanced process monitoring and control tools, quality systems, and global regulations.
  
• Collaborate with cross-functional teams, contribute to regulatory documentation, and lead projects implementing innovative monitoring and control tools to our manufacturing platforms globally, with a strong focus on continuous manufacturing.
  
• Drive standards and apply Lean in the validation and technical transfer of models and/or PAT tools supporting product control strategies across Operations.
  
• Bring a future-focused, innovative mindset to deliver further digitally oriented approaches, data science, predictive modeling and simulation, and artificial intelligence.
  

Minimum Qualifications:

• Ph.D. - 10+ years, MS - 15+ years, BS - 20+ years of relevant industry experience. Degree in relevant fields (Analytical Chemistry, Pharmaceutical Sciences, Engineering, etc.).
  
• Demonstrated delivery in PAT, advanced process control, or model predictive control supporting 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, support of PPQ/CPV, and PAI.
  
• Broad knowledge of pharmaceutical process equipment/ technology for continuous processes.
  
• 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, and conference presentations.
  
• Demonstrated experience in 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).
  

Preferred Qualifications:

• Demonstrated leadership with direct or matrix management of highly skilled scientists.
  
• Experience in the deployment of PAT in manufacturing technologies for multiple formulation deliveries (e.g. oral, inhaled, or injectables).
  
• Knowledge of PAT application in development or manufacturing of combination products is highly desirable.
  
• Experience in working with contract manufacturing organizations to deliver effective PAT solutions.
  

Why AstraZeneca?

We offer an inclusive environment where you can grow your career while making a positive impact on people's lives. Our team is a multigenerational workforce that thrives on curiosity and problem-solving. We are committed to sustainability and leading the way in delivering Lean processes that drive greater efficiency and speed.

Are you ready to step up and lead in a fast-paced environment that rewards commitment and offers diverse career opportunities? Join us at AstraZeneca and be part of our journey towards making people's lives better!

So, what's next?

Don't miss this opportunity to make a meaningful impact on people's lives - apply now!

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 authorization and employment eligibility verification requirements.

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