Responsible for the support of impact or transfer of PAT methods (including chemometric model) in relation to asset strategy projects to AZ or external manufacturing partners.
Takes leadership in developing, maintaining, and collaborating with instrument vendors (including software) and model software vendors to support changes, improvements and issue resolution.
Defines business strategy for the integration of PAT/MSPC in the on-market space.
Leads stakeholder engagement and builds business cases for implementation of new PAT technologies in the on-market space.
Leads, assesses impact & supports complex technical improvements or change activities assuring product performance.
Knowledgeable of vibrational spectroscopy methods and Process Analytical Technology (PAT) applications and provides support to associated models during development and routine use phases.
Supports the development of models used in the application of improving product robustness – including process performance monitoring, process performance predictive modelling, real-time or near real time models, etc. via methods such as MSPC (multivariate statistical process control).
Identifies opportunities for model improvements and digital innovation.
Using domain-specific understanding, translates unstructured, complex business problems into the appropriate data problem, model and analytical solutions.
Researches and develops advanced predictive models and computational methods to guide and shape decision-making within the project scope.
Essential Skills/Experience
Ph.D. – 5+ years, MS – 8+ years, BS – 10+ years of relevant industry experience. Degree in relevant field (Analytical Chemistry, Pharmaceutical Sciences, or Engineering etc.)
Data Analytics, including Chemometrics, Multivariate Data Analysis (MVDA) and Machine Learning with demonstrated success in the development and validation of multivariate methods in a commercial environment.
Expertise in PAT (e.g.: spectroscopic) methods used in association with chemometric models in commercial setting and PAT orchestration (e.g. SIPAT/SynTQ).
Expertise in PAT interface with commercial processes (in-line, on-line, at-line) and control strategy.
Expertise defining business strategy for the integration of PAT/MSPC in the on-market space.
Scientific leadership skills
Understanding of Technology Transfer in the Pharmaceutical industry
Proven track record to think and operate across functional boundaries
Effective influencing and prioritization skills
Good communication and stakeholder management skills
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)
Experience with chemometric modelling software such as SIMCA, Unscrambler, MATLAB, or similar tools for developing, validating, and maintaining multivariate models in a commercial environment.
Knowledge of the principles and management of Safety, Health & Environment (SHE)
Business acumen and capability to understand business cases in subject matter areas.
Desired Skills/Experience
Proven ability to train teams on PAT tools or lead cross-site projects.
Experience working with software vendors for PAT upgrades.
Familiarity with current digital trends in PAT, such as Digital Twins and Simulation models.
Work experience in the pharmaceutical industry in a PAT
Experience in or exposure to multiple subject areas in CMC and related functions
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
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.
