Lead in Process Analytical Technology

Impact patients' lives every day!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.

In Pharmaceutical Technology and Development (PT&D), 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 now looking for a talented Senior Principal Scientist/Principal Scientist, depending on your experience, to strengthen our capabilities in the area of analytical science towards enhanced control strategies. This role will have global responsibilities and can be based at our site in Gothenburg, Sweden or Research Triangle Park/Durham North Carolina, USA.

You will have the chance to lead and 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, and be at the forefront of external interactions.



What you'll do

You will have the opportunity to work in a dynamic and enthusiastic atmosphere, whilst leading in the development and application of process analytical technology to enable enhanced control strategies in support of AstraZeneca's product portfolio. You will work closely with a team of colleagues in a multi-skilled environment to design, develop and deliver high quality PAT methods including model predictive controls, advanced process control, multi-variate data analytics, and predictive models. Continuous improvement will be at the core of everything you do, and you will drive the strategy in the PAT and advanced process control (including model predictive controls/APC/MVDA) area, to ensure that our organization will be on the frontline of emerging technologies and tools, including continuous manufacturing & digital transformation.

Examples of typical tasks:

* Serve as a senior expert/leader within PT&D, mentor colleagues in the field of enhanced control strategies and PAT.
* Drive the scientific knowledge synergy of process analytical technology, PAT method development, and design enhanced control strategies, manufacturing & process technology and process control.
* Take responsibility for the quality, reputation, communication and delivery of PAT science in cross-functional teams delivering drug projects.
* Provide strategic direction and advice on new science and technology within the scientific area of enhanced control strategies with PAT, taking part in tech transfer of these advanced analytical methods and giving consultation to internal and external parties, including medical authorities.
* Continue to develop and drive scientific excellence in the area and advanced process control methodologies and technologies within the company as well as with world leading universities, scientific organizations and other industrial partners.
* Contribute to regulatory documentation and submissions.

Essential requirements:

* PhD within the field of Process Analytical Technology (PAT), advanced process control and/or chemometrics, analytical sciences or similar field, ideally with specialism in an area relevant to application of PAT to support continuous manufacturing.
* Demonstrated delivery of PAT including advanced process control/MVDA, model predictive controls in support of pharmaceutical continuous processing including technology transfer.
* Well versed in ICH Q8, Q9, Q10, Q11 and Q13 guidance's, Quality by Design principles, development and implementation of enhanced approaches for project/product specific control strategies.
* Experience in authoring relevant sections of dossier, support of PPQ/CPV, and PAI.
* Good understanding of theoretical and experimental approaches to advance development and application of enhanced control strategies to support RTR/RTRT opportunities, with emphasis on continuous manufacturing processes. This includes demonstrated expertise in PAT method development and implementation.
* 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.

Our team is a highly collaborative group, working to tight delivery schedules, so the ability to be comfortable working at a fast, goal-oriented pace, with a team-focused approach is crucial to be successful in the role. Furthermore, we believe that you have excellent communication and networking skills and operate confidently and collaboratively with an integrating mind-set.

We see that the applicant is a thought leader and ideally engaged in industry/health authority forums to advance the understanding and application of advanced process control methodologies/technology.

Desirable requirements:

* Strong stakeholder management skills.
* Experience in technology transfer and commercial manufacture using continuous processing.
* Experience in providing support for regulatory submissions
* Demonstrated leadership with direct management of highly skilled scientists is highly desirable.

So, what's next?
We welcome your application no later than July 15th, 2022.