Senior Scientist– Predictive Stability, Pharmaceutical Product Development

AstraZeneca

Gothenburg, Sweden
**
Design and evaluate accelerated predictive stability (aps) studies
Develop stability strategies for drug products
Apply data science tools, including ai/ machine learning (ml)
** AstraZeneca is seeking a Senior Scientist in Predictive Stability for its Global Product Development team in Gothenburg, Sweden. The ideal candidate will have a strong background in pharmaceutical stability studies and experience in predictive modeling, with responsibilities that include designing stability strategies and contributing to regulatory filings. **

Job Summary

  • As a Senior Scientist in Predictive Stability in GPD you will operate across a technical specialism that impacts drug projects portfolio‑wide, from early development to on‑market, and you will be instrumental in expanding this capability globally across sites and functions.
  • Deliver Predictive Stability CMC technical content for contribution to regulatory filings and preparation of successful responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements.
  • 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.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Senior Scientist in Predictive Stability for its Global Product Development team in Gothenburg, Sweden. The ideal candidate will have a strong background in pharmaceutical stability studies and experience in predictive modeling, with responsibilities that include designing stability strategies and contributing to regulatory filings. **

Skills & Requirements

Must-have

  • design and evaluate Accelerated Predictive Stability (APS) studies
  • develop stability strategies for drug products
  • apply data science tools, including AI/ machine learning (ML)
  • interpret analytical data and draw reliable conclusions

Nice-to-have

  • external industry presence in Predictive Stability
  • technical supervision, coaching and mentoring
  • challenge the status quo and seek opportunities for business improvement

Key Requirements

  • BSc, MSc or equivalent with proven track record or PhD with significant experience
  • Experience in designing, deploying and leading strategic initiatives around drug product stability
  • Experience in the application of Predictive Stability modelling
  • Strong understanding of stability indicating critical quality attributes
  • Experience in using AI/ML and other data science tools

Work Rights

Not specified

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