Senior QC Microbiology Specialist for Biologics

BioSpace; Baltimore (MD); On-site; USD 85,000 - 120,000; Full time

Job summary

Syngene in Baltimore, MD seeks a Specialist – Quality Control Microbiology to join the QC unit at a large molecule manufacturing site. The role involves hands-on sampling, testing, method transfer, and cross-functional collaboration to ensure inspection readiness and regulatory compliance.

The ideal candidate has a Bachelor's in Chemistry/Biochemistry or related field and 5–8 years in QC for biologics or pharma, with experience in GLP, audits, and method validation.

Qualifications

• Bachelor’s degree in a related scientific discipline is required.
• 5–8 years of QC experience in biologics or pharmaceutical manufacturing.
• Understanding of GLP, regulatory requirements and audits.
• Working knowledge of biologic techniques and method validation.
• Leadership to guide cross‑functional teams and drive quality.

Responsibilities

• Perform QC microbiology sampling and testing across materials and products.
• Coordinate development, transfer and validation of microbiology methods.
• Ensure compliance with GLP and regulatory standards; support audits.
• Investigate deviations, OOS, CAPA and maintain documentation integrity.
• Collaborate with QA, Manufacturing, Regulatory Affairs and Supply Chain.

Skills

Leadership skills

Cross-functional collaboration

Quality systems

Problem solving

Data integrity

Continuous improvement

Auditing

Education

Bachelor’s degree in Chemistry/Biochemistry/Chemical Engineering

Job description

Syngene in Baltimore, MD seeks a Specialist – Quality Control Microbiology to join the QC unit at a large molecule manufacturing site. The role involves hands-on sampling, testing, method transfer, and cross-functional collaboration to ensure inspection readiness and regulatory compliance.

The ideal candidate has a Bachelor's in Chemistry/Biochemistry or related field and 5–8 years in QC for biologics or pharma, with experience in GLP, audits, and method validation.