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 integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
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.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
Center for Breakthrough Medicines is seeking a Senior Microbiology Lab Manager to join its 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)
- 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
- Manage a team of Microbiologists in the Quality Control department
- Oversees the microbiological testing for Utilities.
- Oversees the microbiological testing for raw materials, in-process materials, intermediates, and final product
- Oversees the environmental monitoring of the clean rooms (under ISO and EU specifications)
- Read, trend, and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
- Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests)
- Prepare and send out samples for microbiological identification
- Maintain historical files on organisms found in classified areas, microbial identification and trending
- Inspection of media fills operations
- Initiate OOS/OOT or Environmental Monitoring Excursion Investigations
- Implement new or Rapid technology to increase efficiency
Key Performance Indicators:
- Delivery of results in time and quality (e.g., review and approve validation, qualification protocols and reports)
- Complete and ensure projects are progressing according to plan and quality expectations.
- Ensure there is a limited number of gaps identified during external and internal audits and in the same context, none of the issues identified are severe / critical
- No critical observations during authority inspections
- No delay with new product introductions caused by the lab
- 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
- Education: BS in microbiology or closely related field with 7 years’ experience in a microbiology lad, 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
- 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
Reports to: Director of Microbiology