Must haves:

• Bachelor’s degree (Biology preferred)
• 5-10 years of experience within pharmaceutical manufacturing
• Experience with testing in the lab (cell culture, growing and fermenting cultures), stability and release testing
• Experience with viable count
• Experience in QC or R&D GMP laboratory
• Experience / Knowledge of LIMS, PDOCS, gQTS, eQMS

Day to day:

This position is focused on Microbiological assays focusing on cell bank testing (e.g. culture purity, viable count method (serial dilution), growth suitability, microbial identification, serotype identity (agglutination) testing). Analyst would be a Laboratory Analyst responsible for ensuring release and routine stability testing of cell banks is completed, within the required time frame. Other responsibilities could include:

• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance
• Responsible for appropriate creation of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, standards, policies, and values.
• Standard Operating Procedure (SOP) revisions, qualification/validation support, leading/participating in projects.