QC Analytical Lead — Microbiology & Biologics

Syngene International Limited; Baltimore (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

Syngene International Ltd. seeks a Principal Specialist – Quality Control Analytical Lead to head the QC Analytical team at a large molecule manufacturing site in Baltimore.

The role requires hands-on QC work, mentoring analysts, and aligning analytical strategies with regulatory requirements and client needs. The incumbent will collaborate with Manufacturing, QA, Regulatory Affairs, and Supply Chain to ensure timely analysis, inspection readiness, and compliant documentation across GLP and

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field is required; Master’s degree is desired.
• 8-12 years of quality control experience in biologics or pharmaceutical manufacturing for large molecule products.
• Understanding of USDA and USFDA, ICH, EU, Health Canada regulations, USP and other pharmacopeial standards relevant to biologics manufacturing.
• Proven experience supporting regulatory inspections and third-party audits.
• Strong working knowledge of biologic analytical techniques and validation of methods.
• Leadership skills to lead cross-functional teams and foster a culture of quality and accountability.

Responsibilities

• Responsible for QC Analytical operations ensuring GLP and regulatory compliance.
• Manage routine analytical tests on raw materials, intermediates, finished products and utilities.
• Lead sampling and testing across analytical tests and coordinate with QA and other departments.
• Ensure qualification, validation, performance, and transfer of analytical methods.
• Interact with clients and project teams to ensure timely execution of activities.
• Maintain documentation including SOPs, IOPs, EOPs, and STPs per control system.

Skills

Leadership

Cross-functional leadership

Quality systems

Regulatory understanding

Audit experience

Continuous improvement

Biologic analytics

Education

Bachelor's degree

Master's degree preferred

Job description

Syngene International Ltd. seeks a Principal Specialist – Quality Control Analytical Lead to head the QC Analytical team at a large molecule manufacturing site in Baltimore.

The role requires hands-on QC work, mentoring analysts, and aligning analytical strategies with regulatory requirements and client needs. The incumbent will collaborate with Manufacturing, QA, Regulatory Affairs, and Supply Chain to ensure timely analysis, inspection readiness, and compliant documentation across GLP and