Director, Microbiology

Position Summary

The Director of Microbiology provides strong leadership, strategic planning, and laboratory system oversight to the Microbiology laboratory team at Exela Pharma Sciences, LLC. The Director of Microbiology is responsible for product sterility testing, bioburden testing, environmental monitoring, and microbial identification. This position requires the ability to priorities testing in alignment with production scheduling and other defined timelines. The individual should be proactive in identifying potential issues, develop effective solutions to technical challenges, and lead team members in the execution of microbiological activities.

Job Responsibilities

• Provide effective strong leadership to the needs of the organization through a demonstration of following Exela's Core Values, experience, and judgment that promotes a culture of accountability and operational excellence.
• Drives continuous improvement strategies and guidance to department staff yielding more efficient, effective, and robust systems that remain compliant
• Ensure cGMP compliance in all aspects of laboratory functions including the testing of raw materials, finished products, and environmental and personnel monitoring.
• Representing the company during contact with the FDA and other regulatory agency audits and with internal/external customers for micro-related matters.
• Provide strategic planning to the Microbiology department through a lifecycle approach to equipment and the continual assessment of compliance with ICH and FDA guidance documents for method capability through a Quality by Design framework.
• Oversee budget and resource allocation, deriving value from laboratory activities while maintaining alignment with site and corporate strategic objectives.
• Oversees laboratory investigations and excursions, change controls, and Deviation/CAPA systems for Microbiological operations.
• Lead, develop, and mentor Microbiology management staff, emphasizing functional and cross-functional teamwork, planning, follow-up, and effective communication.

Experience Requirements

• Advanced knowledge of microbiological practices, procedures, and common analyses, such as Bioburden, Microbial Limits, Sterility, Endotoxin, and Environmental Monitoring.
• Advanced knowledge of aseptic manufacturing regulations, aseptic technique, and clean room behaviors.
• Understanding of Microbiology method development, method transfers, and compendial testing.
• 10+ years demonstrated people leadership experience within a Pharmaceutical testing facility.
• Demonstrated track record of successful application and interpretation of FDA/ICH regulations, industry guidance, and pharmacopeial testing standards.
• Must have a working knowledge of applied statistics.
• Strong demonstrated experience in FDA, corporate, and third-party audits.
• Strong people leadership skills coupled with self-awareness, empathy, relationship management are essential.
• Ability to partner and influence across a matrixed environment
• Excellent communication skills

Education Requirements

• Bachelor's degree in Microbiology, Biology, or other closely related scientific field is required. Master's degree or higher in a similar field is preferred.