Analytical Science and Technology Senior Scientist
Vertex Pharmaceuticals
3 days ago
Remote friendly (Boston, MA)
United States
Operations
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.
Key Duties And Responsibilities:
- 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.
Knowledge And Skills:
- 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.
Education And Experience:
- BS/MS/PhD in Chemistry/Chemical Engineering/Pharmaceutical Chemistry or natural science.
- Typically: PhD + 3+ years; MS + 5+ years; BS + 8+ years.
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.
Key Duties And Responsibilities:
- 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.
Knowledge And Skills:
- 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.
Education And Experience:
- BS/MS/PhD in Chemistry/Chemical Engineering/Pharmaceutical Chemistry or natural science.
- Typically: PhD + 3+ years; MS + 5+ years; BS + 8+ years.