Global PAT Lead for Development and Industrialisation

AstraZeneca • Durham, NC

24d

About The Position

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. 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! AstraZeneca is an equal opportunity employer. We are committed to creating an inclusive environment that accommodates all individuals. If you require accommodations during the application process, please let us know. So, what’s next? Don't miss this opportunity to make a meaningful impact on people's lives – apply now! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Requirements

• 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)

Nice To Haves

• 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.
• 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.

Responsibilities

• 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
• 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
• 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 focussed, innovative mindset to deliver further digitally oriented approaches, data science, predictive modelling and simulation, and artificial intelligence

Benefits

• inclusive environment where you can grow your career
• multigenerational workforce that thrives on curiosity and problem-solving
• committed to sustainability and leading the way in delivering Lean processes that drive greater efficiency and speed
• diverse career opportunities
• equal employment opportunities are available to all applicants and employees
• inclusive and equitable environment where people belong
• commitment to lifelong learning, growth and development for all

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level