Associate Principal Scientist, Process Analytical Technology

Associate Principal Scientist, Process Analytical Technology

Location: Durham, NC

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 an Associate 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 an Associate 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 innovative 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

As an Associate Principal Scientist, 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 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:

- Ph.D. – 3+ years, MS – 5+ years, BS – 8+ years of relevant industry experience. Degree in relevant subject area (Analytical Chemistry, Pharmaceutical Sciences, or Engineering etc.).

- A strong understanding of key process analytical technologies especially NIR, Raman and Microwave Spectroscopy

- Demonstrated expertise in PAT method development, implementation and use of Multi-variate data analysis/ Chemometrics (MVDA, PCA, PLS) in common software platforms (SIMCA, Python, PLS Toolbox etc.)

- 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:

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

- Experience in the deployment of PAT in manufacturing technologies for multiple formulation deliveries (e.g. oral, inhaled or injectables).

- Experience with digital tools supporting enhanced control strategies (DCS, PAT management system, APC, Multivariate monitoring platform)

- Knowledge of PAT application in development or manufacturing of combination products is highly desirable.

- Experience of working with contract manufacturing organisations 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!

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!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.