QC Lead - Bioassay

Cpl Group View all jobs

  • Co Louth
  • Permanent
  • Full-time
  • 13 days ago
QC Lead - Bioassay (Vaccines)Dundalk, IrelandAn exciting opportunity has arisen for an experienced QC Lead - Bioassay to join a state-of-the-art vaccine manufacturing facility in Dundalk. This role offers the chance to lead a high-performing team and play a critical part in delivering high-quality vaccine products that have a global impact.The RoleAs QC Lead, you will be responsible for leading the Bioassay team and ensuring the highest standards in quality control, compliance, and scientific excellence within a GMP environment.Key Responsibilities
  • Lead, develop, and grow a high-performing QC Bioassay team, including recruitment, coaching, and training
  • Act as a technical expert for the development, qualification, and validation of bioassay and cell-based potency methods
  • Review and approve technical documentation including protocols and validation reports
  • Provide technical leadership and evaluate new analytical technologies
  • Oversee quality systems including deviations, investigations, change controls, and CAPAs
  • Manage laboratory scheduling and planning to ensure efficient operations
  • Collaborate with cross-functional teams including Quality Assurance and Regulatory Affairs
  • Support regulatory inspections and GMP audits, driving continuous improvement initiatives
About YouEssential
  • Degree (BSc or MSc) in Biology, Biochemistry, Immunology, Virology, or a related discipline
  • Strong experience in QC and analytical operations within biopharmaceutical or vaccine environments
  • In-depth knowledge of GMP and regulatory requirements (cGMP, ICH, EMA, FDA)
  • Proven leadership and people management experience
  • Strong problem-solving and communication skills
  • Experience working collaboratively across multiple functions
Desirable
  • PhD in a relevant scientific field
  • Significant industry experience (8+ years in vaccines or 10+ years in biopharma)
  • Experience in viral testing and biosafety environments (e.g., BSL-3)
  • Background in CMC development or GMP manufacturing
  • Demonstrated experience driving continuous improvement initiatives
Key Skills
  • Bioassay & Analytical Method Development
  • Cell Culture & Potency Assays
  • GMP Compliance & Quality Systems
  • Deviations, Investigations & CAPAs
  • Laboratory & People Management
  • Vaccine Manufacturing & Virology
What's on Offer
  • Opportunity to lead a critical function within a growing, high-tech facility
  • Work on impactful vaccine products with global reach
  • Collaborative and innovation-driven environment
  • Strong opportunities for career development and progression

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