Vertex Pharmaceuticals
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Cambridge,
MA
Vertex is seeking a talented, experienced pharmaceutical analysis chemist. The incumbent will provide technical support for commercial products developed under QbD. The successful candidate will interact with a highly diverse group of scientists at Vertex and CMOs to solve complex problems encountered in commercial production/manufacturing of intermediates, drug substances, and drug products. The incumbent may also be required to contribute toward the resolution of customer complaints. The role will be hands on and laboratory based. To be considered for this position the applicant will need to be a highly experienced and competent analytical chemist with a history demonstrating judicious choice of analytical technologies to solve challenging analytical problems in the pharmaceutical industry.
The successful candidate will perform analysis of a variety of samples (drug product, drug substance, intermediates, starting materials, etc.) and is expected to be an expert in analytical methods used to release a drug substance and drug product for commerce. The candidate must have experience in chromatography, including:
· HLPC (normal and reverse phase) using UV, EC, ELS, MS
· GC/FID; GC/MS; GC/TCD; HS-GC
· IC with UV and EC detection
In addition the candidate must have experience in
· Dissolution testing
· Particle size analysis
· Pharmacopeial methods
· Analysis of genotoxic impurities
· Impurities/degradation product determination
· Structure elucidation
· XRPD and polymorph composition monitoring/determination
· Investigation of drug substance and drug product contamination
· Familiar with regulatory requirements (GMP), and ICH guidelines
· Familiar with QbD and implementation of continuous improvement strategies.
Minimum Requirements
* Education and experience related to organic analytical chemistry (Ph.D. degree with three to five years experience or a Masters degree with ten years extensive pharmaceutical industry experience)
* At least 2 years of practical experience in analysis of small organic molecules with HPLC-MS
* Very good team-working skills and the capability to work in a complex environment
* Efficient organization and good documentation skills
* Good command of English; excellent presentation and report writing skills.
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.
Cambridge, MA
Cambridge, Massachusetts
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