Associate Principal Scientist - Analytical Sciences

Locations: Gothenburg or Macclesfield

Fixed Term Contract 24 months.

Are you an experienced scientist looking for a role where your expertise can make an outstanding impact? Can you envision joining a dynamic and enthusiastic environment, delivering critical support to commercial products and market access projects? Then this is the place for you!

AstraZeneca is a global, innovative BioPharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world's most serious disease.

We have an exciting opportunity to join as Associate Principal Scientist - Analytical Sciences in the Analytical Science & Technology CoE! In this role you will work within Technical Operations, Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization.

The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle. TOSI is a multi-skilled global organization based in 14 locations in 7 countries, which provide technical leadership and subject matter expert support to AstraZeneca commercial small molecule drug products. Our technical support and expertise spans from formulation, process engineering, analytical, and statistics to devices, packaging and manufacturing technology strategy. The areas in which we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, product launches and regulatory submissions, product robustness, validation and risk evaluation.



What you'll do

As Associate Principal Scientist - Analytical Sciences, you will be responsible to provide analytical subject matter expert support to a group of products for market access activities. Using your knowledge in analytical methods, you will provide expertise and leadership to ensure efficient and effective analytical technology transfers to internal and external sites in multiple countries, aid in the resolution of analytical method issues, support change projects and proactively identify opportunities for analytical method improvements. The role may involve execution of laboratory work, based on project needs. We will also rely on you to train and mentor colleagues and partners in methods used in your expert field.

Your main accountabilities will include:

* Working as analytical SME in multi-functional cross-site teams supporting technology transfer projects to internal and external manufacturing sites.
* Leading and assessing complex technical improvements or change activities, assuring product and methods performance.
* Providing analytical subject matter expertise in support of issues investigations in QC laboratories and manufacturing sites.
* Providing SME support during the regulatory file authoring and the interaction with local authorities for regulatory submissions, variations and license renewals.

Essential for the role

* MSc or PhD degree, complemented with considerable experience in an appropriate subject area such as Chemistry, Pharmacy, Pharmaceutical Sciences or similar.
* Knowledge span across the commercial product requirements in the areas of analytical methods validation, transfer and optimisation, including control of drug products, biopharmaceutics and stability.
* Strong technical leadership, great interpersonal skills and proven track record to lead and collaborate across teams, functions and locations.

You also have:

* Proven knowledge of a broad range of Analytical techniques (standard and non-standard)
* Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
* Significant experience on issue investigation and change assessment from analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc.)
* A detailed understanding of principles, applications and management of SHE and cGMP
* Experience in Operations or R&D with a track record of successful project delivery

Desired for the role

* Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)
* Previous experience and training in Lean, problem solving tools and experience in data analysis and interpretation



Why AstraZeneca

Join our multigenerational team to experience our inclusive and encouraging culture. We believe in shared success, a place where ideas are welcomed and awarded. Be comfortable speaking up, taking responsibility for your actions and working together to succeed. This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.



So, what's next!

If you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be. We look forward to finding out more about you - make sure you apply no later than June 23rd, 2022.

Competitive salary and benefits package on offer.
Opening date: June 8th, 2022
Closing date: June 23rd, 2022

Preferred start date: September 2022.