Job Description
Vertex Pharmaceuticals is seeking a talented individual to join our Boston, MA based Drug Product Facility (DPF).This role supports scientific functions that occur in GMP Operations. This position will provide PAT (Process Analytical Technology) support drug product development, clinical manufacturing for late stage products and commercial manufacturing. Specifically, the role focuses on execution of the automated control strategy and all PAT methods, automation, and data reporting during continuous manufacturing. Additionally, the role supports investigations into all manufacturing related deviations and the implementation of CAPAs.
Key Responsibilities
Vertex Pharmaceuticals is seeking a talented individual to join our Boston, MA based Drug Product Facility (DPF).This role supports scientific functions that occur in GMP Operations. This position will provide PAT (Process Analytical Technology) support drug product development, clinical manufacturing for late stage products and commercial manufacturing. Specifically, the role focuses on execution of the automated control strategy and all PAT methods, automation, and data reporting during continuous manufacturing. Additionally, the role supports investigations into all manufacturing related deviations and the implementation of CAPAs.
Key Responsibilities
- Provide technical and process knowledge to support manufacturing/facilities investigations and the implementation of CAPAs
- Interacting with the Technical Operations and Analytical Development functions to continuously assess the appropriateness of PAT models used for IPC and RTRT through in-process and batch-to-batch trending
- Supporting the development and validation of automated data reporting related to continuous manufacturing
- Troubleshoot analytical methods with the assistance of manager when necessary
- Develop technology applicable to project work
- Performs method validations and transfers
- Participates and/or performs in instrument qualifications
- Maintains accurate notebook entries and adheres to governing SOPs
- Performs data verification/review of peer notebooks
- Authors and reviews SOPs, analytical methods, protocols, and reports
- Performs PAT Operator tasks during GMP manufacturing
- Review PAT data obtained during GMP manufacture to support product disposition
- Participates in OOS investigations
- Maintenance of methods/models during development and after commercial launch
- A Bachelor