APS, Analytical Science and Enhanced Control Strategy

Are you ready for an opportunity to join AstraZeneca in a lead role with a focus on characterization of drug substances and products, developing analytical methods, leading analytical submission activities for all development phases and build science and technology in the area?


We are now looking for a talented Associate Principal Scientist or Senior Scientist, depending on your background, to strengthen our capabilities in the area of analytical science towards enhanced control strategies. We believe that you have significant scientific project-based experience and want to strengthen our team and join us in the Oral Product Development function! This role is based at our site in Gothenburg, Sweden.


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.


At Oral Product Development (OPD) in Gothenburg, a sub-division of PT&D, we focus on the fields of Oral Controlled Release Drug products and Immediate Release Drug Products. You will join a vibrant team that is working on the next generation of medicines and play a key role in the analytical development of new medicinal products.


What you'll do
As an Associate Principal Scientist you will be an analytical science expert with combination of theoretical and technical knowledge to drive our ambition for enhanced control strategy. You will get the opportunity to use your skill to leverage the true opportunities in this arena. The role holder will be part of or leading pharmaceutical analytical project activities, as well as providing input into regulatory submissions.

The role holder will:

* Be an expert in Enhanced Control Strategies and drive implementation in our project based organization
* Be a strong advocate for analytical control strategies in regulatory interactions.
* Have a broad knowledge in develop, validate and implement Process Analytical Technology (PAT) and Real Time Release Testing (RTRT) for continuous as well as batch manufacturing
* Leverage the opportunities of Digitalization and Artificial Intelligence
* Work as a member of cross-functional teams, with a large degree of independence representing own department or area of expertise to lead related analytical chemistry activities.
* Contribute to training and development by acting as coach/mentor, giving immediate feedback, as appropriate. Develop personal performance by actively seeking feedback and support from peers.
* Drive the science of relevant areas of research and contribute as a discussion expert partner within separation science techniques during the different development stages.

We are looking for leaders in analytical chemistry with capability and a desire for continuing to develop scientifically and to drive external visibility for example, through publications, presentations and networking activities.


Essential for the role
* Educational background at research level (PhD) and/or MSc in a discipline relevant to analytical chemistry and at least five years' experience relevant to the position.
* Advanced skills in Enhanced Control Strategies and/or PAT in Batch and or Continuous manufacturing
* Pushing the boundaries of what digitalization can offer.
* Extensive knowledge of spectrophotometric methods, chemometrics, modelling and simulation.
* General knowledge of the analytical area such as method development and method validation and work experience from a regulated environment (GLP/GMP) and from a pharmaceutical company would be advantageous.


Desirable for the role
* Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase.


Why AstraZeneca?
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.


What's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We welcome your application, including CV and cover letter, no later than August 22, 2021.