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Microbiological / Environmental Monitoring Manager And Investigator
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- Job DescriptionJob Title: Microbiological/Environmental Monitoring Manager and InvestigatorLocation: Lexington, MAAbout the role:Primary duties of this position include serving as a lead for various technical aspects of the QC and Mass Bio Ops areas.
- How you will contribute:Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Trend (OOT) and unexpected events.
- Establish microbiological standards to enable best practices and ensure cGMP compliance across QC and Mass Bio Ops. Lead technical improvement initiatives related to microbiological issues and contamination control.
- Liaise and collaborate with key stakeholders (PIER, Manufacturing Sciences, Quality Sciences, Analytical Development and Center functions) as applicable.
- What you bring to Takeda:BS Degree in Science or Engineering with 8 years of relevant experienceProven record of cross-functional technical leadership, including, motivate, and lead technical rigorKnowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies.
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