Associate Principal Scientist – Process Analytical Technology (PAT) and Chemometrics Full-time

Associate Principal Scientist

As an Associate Principal Scientist, you will provide expert support to continuous manufacturing of commercial products. Your knowledge in PAT, analytical science and technologies will be crucial in ensuring efficient and effective support to internal and external manufacturing sites and testing laboratories located in multiple countries.

Responsible expert for the delivery of PAT (instrument, chemometrics, and process control) support for on-market commercial products.

Responsible for the framework lifecycle management of chemometric models related to the commercial supply or testing of drug products, ensuring equivalency for multi-site models.

Management of products knowledge throughout the product lifecycle to enable robust PAT/model use and control strategies.

Identifies opportunities and implements use of PAT to develop process understanding and evolve control strategies, including integration with commercial processes (in-line, on-line, at-line) to deliver business benefits.

Provides support for model updates and validation in the on-market space.

Provides technical expertise and leadership to aid in the resolution of PAT instrument/model-related manufacturing issues and complaints impacting supply, including application of multivariate analysis.

Develops suitable corrective and preventive actions in support of PAT and/or chemometric model related investigations.

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.