Job Description
Be a Subject Matter Expertise (SME) and represent ASAT to lead and participate in method development, validation/verification, transfer, and submission of the rapid safety methods, including but not limited to BacT Sterility and Biofire mycoplasma. Strategize the analytical network for rapid microbiology safety methods and lead the network capacity expansion, including equipment IQ/OQ/PQ for commercial release. Author and/or review technical documents, including method SOPs, study protocols, and technical reports. Author and/or review regulatory documents. Provide SME assessment for deviations and CAPAs. Participate in internal and external meetings.
About Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of innovative medicines for serious diseases.