Manager Environmental Monitoring QC Microbiology

About the Role

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

The Environmental Monitoring QC Manager oversees cleanroom and controlled environment testing in a cell and gene therapy CDMO. The Manager is responsible for leadership and oversight of the environmental monitoring team. They will manage monitoring staff, track microbial data trends, handle investigations and CAPAs (Corrective and Preventive Actions), and ensure compliance with cGMP and FDA standards. Responsible for writing/revising standard operating procedures (SOPs) and supporting equipment qualification and test method validation in compliance with all applicable quality systems and current cGMPs.

How You Will Make an Impact

• Manage routine viable/total particulate, air, surface, and gas testing in cleanrooms.
• Supervise, train, and mentor EM analysts and contractors.
• Review data tracking, trending reports, and environmental excursions in a timely manner.
• Lead investigations for environmental excursions, results, deviations, and write CAPAs.
• Host and support internal and external regulatory inspections (FDA, cGMP).
• Ensure data is accurate and up to date. This includes timely review of documents and cross functional coordination to meet timelines.
• Investigation and troubleshooting of equipment and associated test methods.
• Interact with various support departments to assist with scheduling of services performed in QC Microbiology.
• Identification and implementation of process improvements.
• Development of processes that will support staff and department evaluation and growth
• Ensure that work is completed in accordance with requirements including but not limited to CFR's, cGMPs, SOPs, and company policies.
• Support implementation of information technologies that support documentation and data management systems.

What You Will Bring

• Excellent/Effective written and verbal communications skills.
• Prepare technical data and present to senior leadership.
• Escalate issues professionally and on a timely basis.
• Ability to adhere to timelines for testing and reporting of data
• Ability to function in a team-oriented environment
• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Effective problem-solving capabilities.

Qualifications

• Bachelor's degree in Biology (Microbiology)
• 5 to 10+ years of cGMP pharmaceutical experience
• 2 to 5 years of leadership experience
• Expertise in cleanroom aseptic processing and global regulatory standards (FDA, EU Annex 1)
• Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.

Benefits

• Medical, dental, and vision insurance
• Educational assistance
• 401(k) program
• Additional resources to help you thrive both personally and professionally