Analytical Science and Technology Senior Scientist

General Summary

Senior Scientist, Analytical Science and Technology. Work with CMOs and cross-functional scientists to solve analytical challenges in late-stage development and commercial manufacturing of small-molecule drug products.

• Design and perform elaborate analytical experiments in compliance with regulations and SOPs.
• Lead analytical method transfers to CMOs or between internal groups.
• Support method validation/co-validation for late-phase development and commercial programs.
• Prepare, review, and approve technical documentation (methods, SOPs, transfer protocols/reports, lab and technical records).
• Serve as primary analytical lead for external CMOs; oversee execution and investigations.
• Analyze and trend commercial data to support continued process verification and identify emerging issues.
• Support product lifecycle management and continuous improvement via commercial change control.

• Strong analytical chemistry skills including (U)
  HPLC and GC; strong chromatographic knowledge.
• Analytical development/technical operations experience (late-stage, commercialization, post-approval).
• Problem-solving and root cause analysis expertise.
• Experience with compendial methods (e.g., KF, elemental impurity testing, spectroscopic identification).
• Solid cGMP, ICH, and CMC regulatory knowledge.
• Proficient data analysis/trending/visualization.
• Strong technical writing, communication, collaboration, and project management.

• BS/MS/PhD in Chemistry/Chemical Engineering/Pharmaceutical Chemistry or natural science.
• Typically:
  PhD + 3+ years; MS + 5+ years; BS + 8+ years.