Vertex Pharmaceuticals
Biotechnology
PrincipalScientist,SeparationMethodsExpert,AnalyticalScienceandTechnology(AS&T),VertexPharmaceuticals(Boston)
“Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston) at Vertex Pharmaceuticals. Skills: Separation Methods Expert, Analytical Science, Biologics. Lead analytical method remediation. Lead analytical method validation”
What You'll Achieve.
Deliver medicines to patients
Industry & Context.
Troubleshooting; Investigations; Root cause analysis
What They're Looking For.
Must Have
5+ years relevant work experience, 8+ years relevant work experience, 10+ years relevant work experience, Demonstrated expertise in analytical method development, Demonstrated expertise in validation, Demonstrated expertise in transfer, Demonstrated expertise in lifecycle management, In-depth, hands-on experience in separation methods, Proficiency with regulatory requirements, Proficiency with USP, Proficiency with ICH guidelines
Nice to Have
Familiarity with analytical methods for biological products characterization, Experience in statistical analysis tools, Knowledge of statistical concepts, Excellent communication skills, Good technical writing skills, Proven ability to work with internal and external partners
What You'll Do.
Lead analytical method remediation
Lead analytical method validation
Lead analytical method transfer
Lead troubleshooting for testing
Lead investigations for testing
Support troubleshooting for testing
Support investigations for testing
Own analytical related activities
Collaborate cross-functionally
Support analytical readiness
Support ongoing product lifecycle activities
Be accountable for project success
Ensure on-time deliverables
Support regulatory submissions
Respond to health agency inquiries
Author technical documents
Author method validation protocols
Author method validation reports
Author method transfer protocols
Author method transfer reports
Author method bridging
Author risk assessments
Work with external partners
Review method trending data
How You'll Work.
Team & Collaboration
Internal stakeholders; External partners; CMO/CTO; Contract testing sites
Communication Scope
Technical writing
Process & Methodology
Project management
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