Associate Principal Scientist - Process Analytical Technology
AstraZeneca AB / Kemistjobb / Göteborg
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hela Sverige 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.
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
Essential requirements
* 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
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
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-05-18
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-165681".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
galia.nystrom@astrazeneca.com Jobbnummer 7749447
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