Manager, QC Microbiology

The Role:

ElevateBio is looking for a Quality Control Microbiology Manager for our Pittsburgh facility. This role is responsible for the cGMP compliance of the microbiology laboratory and staff. The manager oversees routine and non-routine microbiology activities, including scheduling and execution of the environmental monitoring program, utilities testing program, and raw material, in-process, and product release testing. The manager also leads method development, method transfer, and method validation. This role owns data review and trending and presents periodic trending reports to senior management.

Here’s What You’ll Do:

• Implement compliant, risk-based environmental and utilities monitoring programs that meet global standards.


• Ensure timely laboratory support to production, including release of manufacturing areas, utilities, raw materials, in-process samples, and finished product results.


• Review, trend, and present microbiological data.


• Review and approve microbiology laboratory SOPs, protocols, and reports.


• Oversee microbiology and environmental investigations, including deviations, out-of-specification results, out-of-trend results, and CAPAs.


• Participate in regulatory inspections and facility audits.


• Serve as the technical subject matter expert for microbiological assays and techniques and troubleshoot microbiology-related issues.


• Support management of the contamination control strategy.


• Hire, train, and develop microbiology staff.

Note: Weekend and evening hours may be required.

Requirements:

• Bachelor’s degree in a technical discipline (Microbiology or related field) with at least seven years of experience in a cGMP Quality Control microbiology laboratory (preferably supporting aseptic manufacturing).


• Two years of prior supervisory experience.


• Hands-on experience with compendial microbiological methods such as endotoxin, bioburden, sterility, environmental monitoring, utilities monitoring, total organic carbon and conductivity, and microbial identification.


• Experience with cleanroom and utilities qualification aligned with ISO 14644, EU GMP Annex 1, and ISO 8573.


• Experience with rapid microbiological methods (e.g., BacT or similar, MCS, and Milliflex Rapid Sterility).


• Ability to communicate effectively and work independently with scientific and technical personnel.


• Ability to work in a dynamic start-up environment.


• Strong knowledge of FDA and global cGMP expectations, quality system processes, and industry practices.


• Strong organizational skills.


• Experience in a cell and gene therapy manufacturing environment is a plus.


• Experience leading laboratory investigations and method qualification activities.


• Competent with standard software tools (e.g., Excel, PowerPoint, and Smartsheet).