Senior QC Microbiology Lead - Biologics Quality

BioSpace; Baltimore (MD); On-site; USD 140,000 - 180,000; Full time

Job summary

Syngene in Baltimore, MD, seeks a Principal Specialist – Quality Control Microbiology Lead to direct the QC Microbiology team at a large molecule manufacturing site. The role combines hands-on testing with leadership, ensuring compliance with GLP and regulatory requirements.

You will oversee environmental monitoring, method transfer/validation, and collaboration across Manufacturing, QA, Regulatory Affairs, and Supply Chain to keep analysis on schedule and compliant with pharmacopeial standards.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline is required; Master’s degree is desired.
• Subject matter expert in Quality Control within biologics or pharmaceutical manufacturing environments.
• Regulatory knowledge including USDA, USFDA, ICH, EU, Health Canada; USP standards.

Responsibilities

• Lead QC Microbiology operations including testing for raw materials, in-process and final products.
• Oversee Environmental Monitoring programs and related qualification activities.
• Ensure QA compliance, CAPA, deviations, and audit responses.
• Coordinate method development, transfer, and validation with QA and other departments.
• Mentor and develop QC Microbiology team and ensure data integrity per ALCOA.

Skills

Quality Control leadership

Regulatory knowledge

Cross-functional collaboration

Laboratory management

Education

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline

Master’s degree preferred

Job description

Syngene in Baltimore, MD, seeks a Principal Specialist – Quality Control Microbiology Lead to direct the QC Microbiology team at a large molecule manufacturing site. The role combines hands-on testing with leadership, ensuring compliance with GLP and regulatory requirements.

You will oversee environmental monitoring, method transfer/validation, and collaboration across Manufacturing, QA, Regulatory Affairs, and Supply Chain to keep analysis on schedule and compliant with pharmacopeial standards.