Center for Breakthrough Medicines is seeking a Senior Microbiology Manager – Environmental Monitoring to join its Microbiology Department. The primary responsibility of the role is to ensure compliance to GxP from the perspective of Environmental and Utility monitoring. This position proactively drives change and improvement to the microbiology lab, while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring, and reporting.
- Maintain the EM Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance.
- Responsible for installation of laboratory equipment and qualification/validation of lab equipment for intended use in laboratory to support EM testing
- Ensure proper oversight and management for protocol development, report writing, trend report and deviation management
- Ensure that priorities (lab scheduling, logistics and flow of activities) for testing and review are set and followed
- Ensure proper scheduling and prioritization of workload and staff to ensure all activities are performed.
- Lead laboratory investigations and facilitates root cause analysis
- Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensure testing, or inspection according to specification and cGMPs
- Ensure programs for trending are in place including assessment for CAPAs based on trend conclusions
- Collaborate with Manufacturing, Supply Chain and Logistics and Quality to ensure an uninterrupted supply of materials for use in Manufacturing
- Oversee the Environmental monitoring and Utility program for manufacturing areas and laboratory areas.
- Develop and Manage the Environmental monitoring and Utility monitoring trending program
- Support the cleaning and disinfection program for the manufacturing areas
- Oversee and develop the inhouse isolates program
- Handle Environmental monitoring and Utility monitoring excursion investigations.
- Participate in audits (internal / external) where necessary (prep, support, interactions) internal/external audit program
- Participate in the preparation and consolidation of the budget of the Quality Unit
- Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
- Collaborate significantly with cross functional groups, including TAS, Manufacturing, Process Development, Facilities, and Regulatory Affairs
- Support implementation of programs such as but not limited to Labware.
- Ensure programs are in place for trending which includes determination of alert and action limits and systems in place to act accordingly
- Ability to maintain integrity and honesty, and always communicate with transparency
- Continuously drive to improve process for improved performance
- Ability to lead and be accountable for team’s performance and results
- Manage internal and external relationships
- Develop strategy and create metrics to measure effectiveness of strategy
- Provide leadership to direct and indirect reports
- Coaching and conflict resolution
- Handle incidents appropriately and with a sense of urgency
- Ability to problem solve and identify root cause
- Ability to communicate at all levels and across all functions
- Ability to build, lead and motivate team
Education & Experience
- Education: BS in microbiology or closely related field with 7 years’ experience in a microbiology lab, preferably in the pharmaceutical or biotech industry; with 3-5 years of that experience in a leadership role in the microbiology lab