Lead QC Analytical Scientist – Biologics (Microbiology)

BioSpace; Baltimore (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

Syngene in Baltimore seeks a Principal Specialist – Quality Control Analytical Lead to oversee the QC Analytical team at a large‑molecule manufacturing site. You will ensure GLP compliance, method qualification, validation, and transfer, while coordinating with QA, Regulatory, Manufacturing, and Supply Chain.

Hands‑on testing, incident investigations, CAPA closure, audits, and regulatory filings support; lead cross‑functional improvements and mentor staff to maintain data integrity and timely

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering or related field is required; Master’s preferred.
• 8–12 years in QC within biologics/pharma manufacturing for large molecule products.
• Understanding of USDA/USFDA, ICH, EU and Health Canada regulations and pharmacopeial standards.
• Experience supporting regulatory inspections and third-party audits.
• Strong leadership and cross-functional collaboration abilities.

Responsibilities

• Lead QC Analytical operations ensuring GLP compliance and regulatory readiness.
• Manage routine analytical tests on materials, intermediates, finished products, and utilities.
• Coordinate with QA and other departments on method development and transfer.
• Ensure qualification, validation, performance, and transfer of analytical methods.
• Lead investigations of deviations, CAPA implementation and audit responses.
• Support regulatory filings and site inspections.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Auditing & inspections

Data integrity (ALCOA)

Education

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

Master’s degree preferred

Job description

Syngene in Baltimore seeks a Principal Specialist – Quality Control Analytical Lead to oversee the QC Analytical team at a large‑molecule manufacturing site. You will ensure GLP compliance, method qualification, validation, and transfer, while coordinating with QA, Regulatory, Manufacturing, and Supply Chain.

Hands‑on testing, incident investigations, CAPA closure, audits, and regulatory filings support; lead cross‑functional improvements and mentor staff to maintain data integrity and timely