Job Overview
We are seeking a highly skilled Senior Microbiologist to provide quality control oversight to our manufacturing operations.
* Provide support to technology transfer and commercial manufacturing operations.
* Review and approve SOPs, risk assessments, change controls, and other documentation associated with drug substance/drug product manufacturing operations.
* Participate in microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation.
* Perform microbial testing and participate in atypical/OOS investigations, change controls, and CAPAs.
* Work with supervisors and other team members to review and monitor method performance.
* Author technical documents, including methods protocols, qualification/validation protocols and reports, SOPs, etc.
* Provide technical guidance and evaluate/introduce new technologies in the microbiology area.
* Assist in developing micro control strategies, quality enhancement, and operational efficiency improvement.
* Communicate effectively with internal and external clients.
Requirements
* BSc in Microbiology or related field and relevant industry experience.
* Demonstrated experience within a highly regulated environment.
* Ability to interpret technical documentation.
* Knowledge of cGxP requirements and regulations.