Senior Scientist-analytical Project Lead, Global Product Development

AstraZeneca

Durham, North Carolina, USA
Hybrid (minimum three days per week in the office)
Analytical chemistry or pharmaceutical sciences degree
Experience with hplc/uplc and lc-ms techniques
Method development, validation, and lifecycle management
AstraZeneca is seeking a Senior Scientist-Analytical Project Lead in Durham, North Carolina, to drive analytical strategy and deliverables for oral solid dosage forms and other product modalities. The ideal candidate should have significant experience in pharmaceutical analytical science, strong leadership skills, and the ability to collaborate across multiple functions to ensure robust methods and compliance with regulatory requirements

Job Summary

  • This role involves leading analytical strategy and delivery for oral solid dosage forms from early development through commercialization.
  • The successful candidate will partner across formulation, engineering, manufacturing, QA, and Regulatory to deliver robust methods and control strategies.
  • AstraZeneca offers an inclusive culture that champions diversity and collaboration while empowering employees to push the boundaries of science.

Matching Summary

Match Score: 85

AstraZeneca is seeking a Senior Scientist-Analytical Project Lead in Durham, North Carolina, to drive analytical strategy and deliverables for oral solid dosage forms and other product modalities. The ideal candidate should have significant experience in pharmaceutical analytical science, strong leadership skills, and the ability to collaborate across multiple functions to ensure robust methods and compliance with regulatory requirements.

Skills & Requirements

Must-have

  • Analytical chemistry or pharmaceutical sciences degree
  • Experience with HPLC/UPLC and LC-MS techniques
  • Method development, validation, and lifecycle management
  • Knowledge of CMC regulatory requirements and submissions
  • Leadership of cross-functional analytical projects
  • GMP/GxP compliance and data integrity expertise

Nice-to-have

  • Experience with inhaled or parenteral product development
  • Championing laboratory automation and AI/ML tools
  • Proficiency in Python/R for data analysis
  • Solid state characterization skills (XRPD, DSC)
  • Strategic chromatographic separation science leadership
  • Six Sigma problem-solving methodology experience

Key Requirements

  • Bachelor's with 12+ years, Master's with 6+ years, or PhD in Analytical Chemistry
  • Significant experience in pharmaceutical analytical science
  • Demonstrated record leading teams in a global organization
  • Hands-on experience with method development under ICH guidelines
  • Experience authoring analytical CMC content for IND/NDA submissions

Work Rights

Not specified

Tailored Resume

Cover Letter