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AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Principal Scientist - Process Analytical Technology, Chemometrics

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeWuxi, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

  • A Ph.D. with at least 5 years, a master's degree with at least 8 years, or a bachelor's degree with at least 10 years of relevant industry experience in a relevant field such as Analytical Chemistry, Pharmaceutical Sciences, or Engineering.
  • Demonstrated success using data analytics, including chemometrics, multivariate data analysis, and machine learning to develop and validate multivariate methods in a commercial environment.
  • Expertise in spectroscopic Process Analytical Technology methods used with chemometric models in commercial settings and PAT orchestration tools such as SIPAT or SynTQ.
  • Expertise integrating PAT with commercial processes, including in-line, on-line, and at-line applications, and associated control strategies.
  • Expertise defining business strategy for integrating PAT or multivariate statistical process control in the on-market space.
  • Scientific leadership skills.
  • Understanding of technology transfer in the pharmaceutical industry.
  • Ability to work across functional boundaries.
  • Influencing and prioritization skills.
  • Communication and stakeholder management skills.
  • Strong understanding of process analytical technologies, especially NIR, Raman, and microwave resonance spectroscopy.
  • Expertise in PAT method development, implementation, optimization, and use of multivariate data analysis and chemometrics, including MVDA, PCA, and PLS.
  • Experience with chemometric modeling 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 and Environment.
  • Business acumen and ability to understand business cases in relevant subject areas.

Responsibilities

  • Provide expert support for continuous manufacturing of commercial products across internal and external manufacturing sites and testing laboratories.
  • Deliver Process Analytical Technology support, including instruments, chemometrics, and process control, for on-market commercial products.
  • Manage the framework lifecycle of chemometric models related to commercial supply or drug-product testing, ensuring equivalency for models used across multiple sites.
  • Manage product knowledge throughout the product lifecycle to enable robust PAT and model use and control strategies.
  • Identify opportunities to apply PAT, develop process understanding, and evolve control strategies, including integration with commercial processes to deliver business benefits.
  • Support model updates and validation for on-market products.
  • Provide technical expertise and leadership to resolve PAT instrument- or model-related manufacturing issues and complaints affecting supply, including through multivariate analysis.
  • Develop corrective and preventive actions for PAT or chemometric-model investigations.
  • Support the impact assessment or transfer of PAT methods, including chemometric models, for asset-strategy projects involving AstraZeneca or external manufacturing partners.
  • Lead collaboration with instrument vendors, including software vendors, and model-software vendors to support changes, improvements, and issue resolution.
  • Define business strategy for integrating PAT and multivariate statistical process control in the on-market space.
  • Lead stakeholder engagement and build business cases for implementing new PAT technologies in the on-market space.
  • Lead and assess the impact of complex technical improvements or change activities, and support them to assure product performance.
  • Apply knowledge of vibrational spectroscopy methods and PAT applications to support associated models during development and routine use.
  • Support development of models to improve product robustness, including process-performance monitoring, predictive modeling, and real-time or near-real-time models using methods such as multivariate statistical process control.
  • Identify opportunities for model improvements and digital innovation.
  • Translate complex, unstructured business problems into appropriate data problems, models, and analytical solutions using domain-specific understanding.
  • Research and develop advanced predictive models and computational methods to guide decision-making within project scope.

Desired Qualifications

  • Ability to train teams on PAT tools or lead cross-site projects.
  • Experience working with software vendors on PAT upgrades.
  • Familiarity with digital trends in PAT, such as digital twins and simulation models.
  • Work experience in the pharmaceutical industry in PAT.
  • Experience or exposure to multiple subject areas in CMC and related functions.
  • Understanding of other key analytical techniques such as separation science, NMR, and mass spectrometry.
  • Previous experience and training in Lean, problem-solving tools, data analysis, and interpretation.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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