Multinational CMO is looking to hire an Associate Director of Microbiology. Quartered in Houston, TX this could be the move you need to escape these cold winter months!
- Responsible for supervision of the Microbiology assay and EM teams. Acts as an advisor to team members when determining how to meet schedules and/or resolve technical problems.
- Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
- Responsible for development of site Environmental and Utility monitoring programs and policies.
- Owns site environmental monitoring and utility trend program
- Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
- Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
- Responsible for monitoring QC resource capacity.
- Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
- Prepares project plans, writes status reports, and gives oral presentations to customers and management.
- Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances.
- Bachelor of Science degree required, advanced degree preferred (eg MS)
- Experience hands-on knowledge in management / leadership role
- Proven experience developing department budgets, monitoring and escalating variances
- Working knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required.
- Experience performing trending of environmental/utility monitoring data and conducting contamination/excursion investigations required.
- In-depth understanding of concepts and principles in own discipline and a basic knowledge of these elements in other areas. Stays aware of new technologies and potential applications in area.
- Develops training plans and performs identification and remediation of training gaps.
- Knowledge of SAP and TrackWise systems