Principal Specialist – Quality Control Microbiology Lead

About the role

The Principal Specialist – Quality Control Microbiology Lead will oversee QC Microbiology operations at a large molecule manufacturing plant. This role ensures compliance with GLP and regulatory requirements, manages environmental monitoring programs, and collaborates with various departments to support project activities.

Responsibilities

• Manage QC Microbiology operations, including stability studies, raw material testing, and facility utilities testing.
• Lead the Environmental Monitoring program, including EMPQ and WFI qualification.
• Perform routine microbiological tests on raw materials, intermediates, and finished products.
• Draft, execute, and review/approve contamination control strategies and disinfectant efficacy studies.
• Coordinate with QA and other departments for microbiological test development and method transfer.
• Ensure compliance with regulatory requirements and maintain documentation.
• Investigate QC test incidents, OOS, deviations, and client complaints.
• Support regulatory filings and ensure lab safety.
• Coach and develop the QC Microbiology team.
• Monitor QC microbial trends and drive continuous improvement.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Master’s degree preferred.
• Subject matter expert in QC within biologics/pharmaceutical manufacturing, especially for large molecule products.
• Understanding of USDA, USFDA, ICH, EU, Health Canada regulations, USP, and other pharmacopeial standards.
• Proven experience supporting regulatory inspections and third-party audits.
• Strong technical expertise in biologic analytical techniques and method validation.
• Leadership skills in leading cross-functional teams and fostering a culture of quality, compliance, and accountability.
• Experience in planning and managing resources for QC microbiology lab operations.

Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Master’s degree preferred.
• Regulatory Knowledge: Understanding of USDA and USFDA, ICH, EU, Health Canada regulations, USP, and other pharmacopeial standards relevant to biologics manufacturing.
• Audit Experience: Proven experience supporting regulatory inspections and third-party audits.
• Technical Expertise: Strong working knowledge of biologic analytical techniques and validation of methods.
• Leadership Skills: Demonstrated ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
• Training & Development: Skilled in implementing robust quality systems, qualifications and validations, and product lifecycle quality management.
• Continuous Improvement: A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.