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- 6+ years of experience for more senior, 3+ for junior level
- Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.
- Experience with purity testing, viability, suitability of growth, streaking and isolating colonies, media making, Bioburden, water testing (do not have to have all of these – but at least several)
- Understanding of aseptic laboratory techniques and quality systems
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
- Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
- Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
- Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
- Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
- Train junior colleagues and develop training plans and oversee training activities for groups.
- Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.
- Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
- Perform laboratory support functions and maintain work area in a neat and orderly manner.
- Write Standard Operating Procedures, technical reports, project plans and other documents independently.
Microbiologist - Sanford, United States - Insight Global
Description
Microbiologist Requirements:
Job Description:
As a Microbiology Senior Scientist, you will be responsible for analyzing drug product, drug substance and environmental monitoring microbiological contamination to support our quality programs. Your contribution to environmental testing, bioburden testing, endotoxin testing, microbial identifications, and sterility testing.