Senior Scientist, Drug Substance Analytical Development
Vertex Pharmaceuticals LLC
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Benefits offered by this job
Job summary
Vertex Pharmaceuticals LLC, based in Boston, seeks an experienced scientist to advance small molecule drug substance process development and analytical control strategies across development stages. You will design, oversee, and optimize analytical activities, collaborating with CMC and external labs while driving innovative solutions in a fast-paced environment.
Applicants should hold a Ph.D. with extensive analytical development experience and demonstrate strong knowledge of cGMP/ICH
Qualifications
- Ph.D. with 4+ years of relevant analytical development experience
- Strong knowledge of cGMP, ICH, FDA, USP guidelines and impurity control
- Experience designing and executing drug substance process development analytical activities
Responsibilities
- Design and oversee drug substance analytical activities across all development phases
- Set and justify drug substance specifications with clinical study design
- Collaborate with contract manufacturing/testing labs and internal CMC functions
- Develop analytical methods and retest/storage conditions for starting materials and intermediates
- Communicate critical analytical issues to cross-functional teams
Skills
Education
Tools
Job description
Vertex Pharmaceuticals LLC, based in Boston, seeks an experienced scientist to advance small molecule drug substance process development and analytical control strategies across development stages. You will design, oversee, and optimize analytical activities, collaborating with CMC and external labs while driving innovative solutions in a fast-paced environment.
Applicants should hold a Ph.D. with extensive analytical development experience and demonstrate strong knowledge of cGMP/ICH
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