Biologics Quality Control Section Head

About the role

EVA Pharma, a pharmaceutical company dedicated to health and well-being, is looking for an experienced Biologics QC Section Head to lead laboratory operations. The role ensures the quality, safety and compliance of biological and biosimilar products through analytical testing and biological activity assessment.

Key responsibilities

• Lead QC testing and characterization of biological and biosimilar products in line with GMP and approved specifications.
• Oversee analytical testing using LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE and microplate readers.
• Lead bioassays for biological activity and potency, including execution, data interpretation, troubleshooting and validation.
• Manage method transfer, verification, validation and troubleshooting for new and existing products.
• Review analytical data and lead investigations of OOS/OOT results, deviations and incidents, driving root-cause analysis and CAPA.
• Oversee stability testing and evaluation of stability data.
• Ensure compliance with GMP, data integrity and regulatory standards.
• Lead and develop the QC team, support internal and external audits and regulatory inspections.

Required profile

• Bachelor's degree in Science, Biochemistry, Biotechnology or a related field.
• 6+ years in quality control or quality assurance in the pharmaceutical or related industry.
• Hands-on experience in bioassay testing, potency assessment and assay validation is essential.
• Previous team leadership or supervision experience is preferred.

Required skills

• Practical experience with LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE and microplate readers.
• Strong knowledge of GMP, data integrity, laboratory investigations and pharmaceutical quality systems.