Analytical Science and Technology Senior Scientist
$122,400–$183,600 year
Hybrid · Boston, Massachusetts, United States
Job Summary
Senior Scientist in Analytical Science and Technology responsible for designing and executing complex analytical experiments, leading analytical method transfer to CMOs or internal groups, and supporting method validation for late-stage development and commercial programs. Role involves preparing and approving technical documentation (analytical methods, SOPs, transfer protocols), analyzing and trending commercial data for process verification, and driving continuous improvement through change control. Candidates must have a strong foundation in analytical chemistry (UHPLC, HPLC, GC), familiarity with cGMP and ICH guidelines, experience with compendial methods (e.g., KF, elemental impurity testing), and excellent technical writing and cross-functional collaboration skills. Education path includes PhD with 3+ years of relevant experience or Master’s with 5+ years or Bachelor's with 8+ years; ability to operate in a fast-paced, matrixed environment and manage projects.
Required Qualifications
- PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry or related natural science
- 3+ years of analytical development, technical operations, or related experience for late-stage development, commercialization and post-approval activities (if Master’s, 5+ years; if Bachelor's, 8+ years)
- Strong practical analytical chemistry skills including UHPLC, HPLC, and GC
- Experience with consolidating and applying compendial methods (e.g., KF, elemental impurity testing, spectroscopy)
- Solid understanding of cGMP regulations and ICH guidelines; familiarity with CMC regulatory expectations
- Proficiency in data analysis, trending, and visualization to support decision-making
- Excellent communication, collaboration, and technical writing skills; ability to work in fast-paced, matrixed environments
- Proven ability to lead method transfer activities to CMOs or internal groups
- Experience with method validation or co-validation for late-stage development and commercial programs
- Ability to prepare, review, and approve technical documentation (analytical methods, SOPs, transfer protocols, reports)
- PhD and 3+ years OR Master’s and 5+ years OR Bachelor’s and 8+ years of related experience
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