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Job Summary

We are seeking an experienced Biologics QC Section Head to lead laboratory operations, ensuring the quality, safety, and compliance of biological and biosimilar products through robust analytical testing and biological activity assessment.

Key Responsibilities:

• Lead QC testing and characterization of biological and biosimilar products in compliance with GMP requirements and approved specifications.
• Oversee analytical testing using LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate readers.
• Lead bioassay testing for biological activity and potency, including assay execution, data interpretation, troubleshooting, and validation, ensuring reliable and scientifically sound results.
• Manage analytical method transfer, verification, validation, and troubleshooting for new and existing products.
• Review analytical data and lead investigations into OOS/OOT results, deviations, and laboratory incidents, ensuring effective root-cause analysis and CAPA implementation.
• Oversee stability testing and evaluation of biological product stability data.
• Ensure compliance with GMP, data integrity requirements, and applicable regulatory standards.
• Lead and develop the QC team, ensuring timely testing, laboratory efficiency, and continuous improvement.
• Support internal and external audits and regulatory inspections.

Requirements

• Bachelor’s degree in Science, Biochemistry, Biotechnology, or a related field.
• 6+ years of experience in quality control or quality assurance within the pharmaceutical or related industry.
• Hands-on experience in bioassay testing, biological activity and potency assessment, and assay validation is essential.
• Practical experience with LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate reader-based techniques.
• Strong knowledge of GMP, data integrity, laboratory investigations, and pharmaceutical quality systems.
• Previous experience in team leadership or supervision is preferred.