Senior Scientist, QC Microbiology Lead

BioSpace; Baltimore (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Syngene in Baltimore, MD seeks a Principal Specialist – Quality Control Microbiology Lead to manage the QC Microbiology unit for a large molecule manufacturing site. You will lead a team, drive regulatory alignment, and partner with Manufacturing, QA, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness.

The role combines hands-on QC work with leadership of analysts, CAPA actions, and continuous improvement initiatives to enhance product quality and compliance.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field.
• Subject matter expert in QC within biologics or pharmaceutical manufacturing.
• Regulatory knowledge across USDA, US FDA, ICH, EU, Health Canada; USP standards.
• Audit experience supporting regulatory inspections and third-party audits.
• Strong working knowledge of biologic analytical techniques and method validation.

Responsibilities

• Oversee QC Microbiology operations in a GLP-compliant environment.
• Lead Environmental Monitoring program and related qualification activities.
• Coordinate with QA and other functions to transfer microbiology tests/methods.
• Ensure qualification, validation, and transfer of microbiology methods.
• Review and close audit observations related to QC Microbiology.
• Maintain SOPs, IOPs, EOPs, and STPs per documentation control.

Skills

QC microbiology leadership

Regulatory knowledge

Quality systems & CAPA

Cross-functional collaboration

Education

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

Master’s degree preferred

Job description

Syngene in Baltimore, MD seeks a Principal Specialist – Quality Control Microbiology Lead to manage the QC Microbiology unit for a large molecule manufacturing site. You will lead a team, drive regulatory alignment, and partner with Manufacturing, QA, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness.

The role combines hands-on QC work with leadership of analysts, CAPA actions, and continuous improvement initiatives to enhance product quality and compliance.