Associate Principal Scientist – Process Analytical Technology
Location: Cheshire East
Job Type: Full time
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 join us in this exciting opportunity!
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
We have a great opportunity for you to join the Analytical Science & Technology CoE within Technical Operations, Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization. We are looking for an enthusiastic Associate Principal Scientist - Process Analytical Technology (PAT) in Sweden or UK with experience in the application of PAT, to support continuous manufacturing of oral solid dosage forms (OSDs) and inhalation products.
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, 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
This is a key role to support the transformation of AZ commercial manufacturing through continuous direct compression (CDC) for OSDs and through large scale particle dryers (LSPD) for inhalation products. You will be responsible to provide subject matter expert support to continuous manufacturing of commercial products. Using your knowledge in PAT, analytical science and technologies, you will provide expertise and leadership to ensure efficient and effective support to internal and external manufacturing sites and testing laboratories located in multiple countries. You will work closely with teams in a multi-skilled environment in the implementation and lifecycle maintenance of high quality PAT methods utilising multi-variate data analysis and predictive models. You will help PT&D and manufacturing sites to develop “cutting edge” science applications in PAT to support the implementation and maintenance of enhanced control strategies for drug products.
Main accountabilities will include:
- Providing PAT expertise in close collaboration with PT&D development teams, manufacturing sites and external organisations to support development, implementation and optimization of enhanced control strategies including real-time release testing (RTRT).
- Supporting Technology Transfer and Validation of PAT methods and technologies for commercial manufacturing processes
- Providing expert support to PAT methods and technologies across the commercial lifecycle of drug products, to ensure they remain fit for purpose and in compliance with the evolving regulatory requirements.
- Leading and assessing complex technical changes and playing a proactive role in seeing opportunities for PAT method improvements.
- Providing subject matter expertise in support of issues investigations in QC laboratories and manufacturing sites. Providing technical leadership to Issue Management Team (IMT).
- Providing SME support during the regulatory file authoring and the interaction with worldwide authorities for regulatory submissions, variations and license renewals.
- Developing solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis.
- Supporting the definition of standards impacting commercial products, specific to regulatory expectations and good business or quality standards.
- Providing project resource estimations and capital equipment proposals for the development of PAT including new technology assessment and continuous improvement.
- Supporting the development of other colleagues and existing user groups through coaching, mentoring and training to enable further PAT utilisation
- MSc or PhD degree in a relevant subject area with proven experience in the use of PAT in the Pharmaceutical or Chemical industries and/or postgraduate experience in Academia with a PAT industrial focus.
- Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of using risk-based approaches for successful delivery.
- Proven track record to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement.
- Effective influencing and prioritization skills to ensure project delivery to deadlines.
- Good communication and stakeholder management skills, and the ability to discuss complex ideas in a simple, easy to understand manner.
- A good understanding of the overall drug development and commercialization process from development, launch and through life cycle management
- A strong understanding of key process analytical technologies, especially NIR, Raman and microwave resonance spectroscopy
- Demonstrated expertise in PAT method development, implementation, optimization and use of Multi-variate data analysis/ Chemometrics (MVDA, PCA, PLS)
- Good understanding of theoretical and experimental approaches to advance the development and application of enhanced control strategies supporting RTR opportunities
- Experience in 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.)
- Knowledge of the principles and management of Safety, Health & Environment (SHE)
- Business acumen and capability to understand business cases in subject matter areas.
Desired for the role
- Work experience in the Pharmaceutical industry in a PAT based role
- Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)
- An understanding of other key analytical techniques such as separation science, NMR and mass spectrometry
- Previous experience and training in Lean, problem solving tools and experience in data analysis and interpretation
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next
We welcome your application no later than May 28th, 2023!
Competitive salary and benefits package on offer.
Opening date: May 8th, 2023
Closing date: May 28th, 2023
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 authorization and employment eligibility verification requirements.