Associate Principal Scientist - Process Analytical Technology

Associate Principal Scientist - Process Analytical Technology

Location: Durham, NC

Introduction to role:

Are you ready to make a meaningful impact on people's lives with life-changing medicines? We are looking for an Associate Principal Scientist to join our Operations team in Research Triangle Park, Durham, NC. At AstraZeneca, we are driven by our commitment to deliver more medicines to patients, quicker and more affordably. We are currently looking for an Associate Principal Scientist in Process Analytical Technology in our Product and Process Control unit. If you have significant scientific and drug project experience, we want you to strengthen our team by joining us in PT&D.

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.

Accountabilities:

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. 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.

You will have the chance to set clear directions for the organization in groundbreaking 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.

Essential Skills/Experience:

• Ph.D. – 3+ years, MS – 5+ years, BS – 8+ years of relevant industry experience. Degree in relevant field (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 Skills/Experience:

• 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 organizations to deliver effective PAT solutions.

When we put unexpected 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 take Quality seriously. Our work is important and valued. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We are strong communicators and networkers. With constant exposure to different tasks, we're at our best when we're working together as a team. We get our pipeline out to patients sustainably, reliably, and safely. The voice of the patient. we certify every batch and ensure manufacturing supplies move without challenges.

Are you ready to champion a mindset of excellence? Join an environment of excellence at AstraZeneca! 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 authorisation and employment eligibility verification requirements.