Manager, QC - Microbiology

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from Firstin Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose built for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

The Manager of Quality Control - Microbiology is responsible for managing a team of QC professionals and overseeing the daily operations of the environmental monitoring and utility monitoring programs and microbiology testing at Bora Biologics Rockville site to ensure compliance with cGMP standards and the current EU GMP Annex 1 expectations for contamination control. This person will interact extensively with other department supervisors, Quality personnel, Manufacturing personnel, other business partners, and external clients and sponsors.

This person will also be responsible for the development, transfer and validation of microbial test methods. The Manager supports the microbiological elements of the site Contamination Control Strategy and ensures the integrity (ALCOA+) of all microbiological data across manual and electronic records. This role also supports client- and sponsor-facing quality activities, and readiness for client audits and regulatory inspections.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Manages the team to ensure that priorities for lab scheduling, logistics and flow of activities for testing and review are established and followed and that workload is also prioritized and staffing is optimized to ensure timely and effective performance.
• Supervise and monitor the team to ensure that the environmental monitoring of the clean rooms and GMP facilities are performed under ISO and EU specifications and the current EU GMP Annex
  1. Address any deficiencies appropriately.
• Contribute to and maintain the microbiological elements of the site Contamination Control Strategy in alignment with the current EU GMP Annex 1, including supporting facility, utility, personnel, equipment, and process contamination risk assessments.
• Read, trend and report testing results to assess compliance and control of facility, utilities, and manufacturing process and recommend any needed changes to senior management.
• Monitor the GMP systems currently in place to ensure compliance with documented policies and regulatory guidance documents and respond to deficiencies appropriately.
• Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures. Lead/support laboratory investigations and facilitate root cause analysis.
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes. Gather metric information for use in continuous improvement of Microbiology area.
• Develop, revise and review SOPs, qualification/validation protocols and reports, and help execute validation studies to support the validation and qualification of manufacturing area.
• Ensure proper oversight and guidance for direct reports in the areas of protocol development, report writing, trend report and deviation management.
• Review proposed changes to EM and utility systems, procedures, methods, as appropriate.
• Participate in and prepare for internal /external audits where necessary.
• Train and mentor staff on technical concepts and methods. Develop and implement mechanism for assessing knowledge and understanding.
• Collaborate with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Clients whenever necessary.
• Ensure data integrity (ALCOA+) across all QC Microbiology records, including LIMS entries, , and manual records.
• Support client- and sponsor-facing quality activities, including responding to client questions on environmental monitoring trends and excursion investigations, and participating in client audits.
• Support the transfer, qualification, and validation of microbial test methods for incoming client products and manage the environmental and utility monitoring programs across a multi-product, multi-campaign CDMO environment.
• Own QC Microbiology performance metrics (e.g., turnaround time, right-first-time, on-time testing) to support batch release schedules and client commitments, and drive continuous improvement.
• Where applicable to site operations, ensure appropriate aseptic practice, personnel and gowning qualification, and viable personnel monitoring programs.
• Perform other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this…