Manager, Quality Control Microbiology

oxfordbiom•Durham, NC

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Manager, Quality Control, Microbiology to join us. In this role, you will be responsible for leading and overseeing Quality Control Microbiology activities in support of commercial cell and gene therapy manufacturing operations., playing a key part in advancing our mission and making a real difference.

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific discipline.
Minimum of 5 years of experience in the biopharmaceutical industry, including hands-on experience supporting aseptic processing and sterile manufacturing environments.
At least 2–3 years of supervisory or people leadership experience in a QC Microbiology laboratory setting.
Demonstrated track record of leading QC Microbiological testing activities in support of GMP manufacturing.
Strong working knowledge of cGMP, FDA, EU, ICH, and other applicable regulatory requirements related to microbiology and sterility assurance.

Nice To Haves

Experience supporting commercial manufacturing operations preferred; experience in site start-up or facility expansion is a plus.

Responsibilities

Lead, manage, and develop the QC Microbiology team, fostering a culture of quality, scientific rigor, and continuous improvement.
Develop, maintain, and execute microbiological testing strategies and supporting documentation in accordance with cGMP and regulatory expectations for commercial cell and gene therapy products.
Manage and maintain the Environmental Monitoring (EM) and Utility Monitoring programs, including routine oversight, data review, and preparation of quarterly and annual trend reports.
Own and maintain the site sterility assurance program, ensuring compliance with product specifications, regulatory requirements, and industry standards, including aseptic processing expectations.
Plan, prioritize, and oversee QC Microbiology testing activities to ensure alignment with manufacturing schedules and site timelines.
Author, review, and approve SOPs, policies, protocols, and technical reports related to microbiology and sterility assurance.
Review, approve, and provide technical oversight for QC Microbiology investigations, deviations, and associated CAPAs.
Lead and support CAPA and continuous improvement initiatives to strengthen microbiological controls and laboratory performance.
Serve as the primary microbiology SME, partnering with Quality Operations, Quality Assurance, Manufacturing, Facilities, and Engineering to support day-to-day operations and issue resolution.
Provide microbiology and sterility assurance expertise for facility design, equipment qualification, process changes, and contamination control strategies.
Participate in and support regulatory filings, client audits, and health authority inspections, including preparation of documentation and responses to inspection observations.
Manage, develop, and maintain the Environmental Monitoring and Utility Monitoring Programs, and prepare quarterly and annual trend reports
Accountable for managing the sterility assurance program to ensure quality, products specifications, and adherence to current regulations
Author, review, and/ or approve SOPs/policies and technical reports
Review and approve QC Microbiology investigations and deviations
Interface with cross-functions teams service as SME for Microbiology