The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization.
CBM's mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
Center for Breakthrough Medicines is seeking a Senior Manager - Microbiology Testing, to join its growing Microbiology Department. The primary responsibility of the role is to ensure compliance to GxP from the perspective of Quality Control (Microbiological Testing and Environmental Monitoring, Mycoplasma detection, Raw Material consumable, excipient, API testing and release and Stability). This position proactively drives change and improvement to the QC microbiology lab, while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring, and reporting.
* Maintain the QC Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance while ensuring Method lifecycle management in these areas
* Responsible for installation of laboratory equipment and qualification/validation of lab equipment for intended use in QC laboratory to support testing (e.g., Mycoplasma detection, Bioburden, Endotoxin, Sterility Testing)
* Manage a team of Microbiologists in the Quality Control department
* 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 in a timely manner
* Lead laboratory investigations and facilitates root cause analysis
* Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensure that materials or final products have been manufactured, tested, or inspected 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
* 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 QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs
* 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
* Ability to maintain integrity and honesty, and always communicate with transparency
* Ability to lead and be accountable for team's performance and results
* Ability to problem solve and identify root cause
* Ability to communicate at all levels and across all functions
* Experience building, leading, and motivating a team