Principal Scientist - Process Analytical Technology (PAT)

Principal Scientist - Process Analytical Technology (PAT)

Location: Mt. Vernon, IN

Introduction to Role:

Are you ready to make an outstanding impact in the world of science? We have an exciting opportunity for you to join our dynamic and enthusiastic team at AstraZeneca, where we turn ideas into life-changing medicines. We are looking for a Principal Scientist - Process Analytical Technology (PAT) to join our Technical Operations, Science and Innovation (TOSI) team. This role is pivotal in supporting the transformation of AZ commercial drug product manufacturing and introduction of enhanced control strategies, for example to our new continuous direct compression (CDC) lines for oral solid dosage forms (OSDs).

Accountabilities:

As a Principal Scientist – Process Analytical Technology, you will provide expert support to continuous manufacturing of commercial products. Your knowledge in PAT will be crucial in ensuring efficient and effective support to internal and external manufacturing sites located in multiple countries. You will play a proactive role in finding opportunities for introduction of new PAT technology and established method improvements and provide technical leadership to Issue Management Teams (IMTs). In addition, you will play a crucial role in driving the lifecycle management of 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 also bring a future focussed, innovative mentality to deliver further digitally oriented approaches, data science, predictive modelling and simulation and artificial intelligence. 

Essential for the role:

• Ph.D. – 10+ years, MS – 15+ years, BS – 20+ years of relevant industry experience. Degree in relevant field (Analytical Chemistry, Pharmaceutical Sciences, or Engineering etc.). 
• Demonstrated delivery in PAT, advanced process control or model predictive control in support of pharmaceutical manufacturing including technology transfer. 
• Well versed in ICH guidelines (Q2, Q6, Q8, Q9, Q10, Q12, Q13 and Q14), Quality by Design principles, development and implementation of enhanced approaches for project/product specific control strategies.   
• 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, conference presentations. 
• 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) 
• Discernment and capability to understand business cases in subject matter

Desired Skills/Experience:

• Demonstrated leadership with building organisational capability.
• Experience in the deployment of PAT in manufacturing technologies for multiple formulation deliveries (e.g. oral, inhaled or injectables). 
• Knowledge of PAT application in manufacturing of combination products is highly desirable. 
• Experience of working with contract manufacturing organisations to deliver effective PAT solutions
• Experience in or exposure to multiple subject areas in CMC and related functions
• Previous experience and training in Lean, problem-solving tools and experience in data analysis and interpretation

The global position would sit at the Mount Vernon AZ Supply Site which is a major manufacturing site in the US and is the regional Digital Lighthouse site. It boasts a diverse, inclusive, and innovative atmosphere. Mount Vernon is located in the Evansville metropolitan area which offers numerous attractions, including the #2 Nationally ranked Signature High School, the University of Evansville, and the University of Southern Indiana. The area also features minor league baseball and hockey teams, several event centers which draw major performing artists. Additionally, the area has a convenient regional airport and is just a 2 to 3-hour drive from Indianapolis, Louisville, St. Louis, and Nashville.

When we put multidisciplinary 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.

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We are leading the way in delivering Lean processes that drive greater efficiency and speed.  We strive to build a high-performing network that values both efficient execution and a collaborative team environment.

Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products. Are you ready to make a positive impact on society through our sustainability goals? Join us now and be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030. Everyone can contribute towards our collective legacy of doing good for people, the environment and society.

Apply now to be part of our journey!