Senior QC Microbiologist Team Lead

We are seeking an experienced QC Microbiology Team Lead to oversee all microbiological and sterility testing related to API testing. This role goes beyond laboratory operations and involves all activities affecting the microbial quality of our products, including process validation, cleaning validation, method validation/transfer, environmental monitoring, aseptic manufacturing, and critical site utilities.

Key Responsibilities:

• Lead, mentor, and supervise the QC Microbiology team.
  

• Implement and oversee methods, procedures, and evaluations for inspection and testing.
  

• Monitor team performance, provide feedback, and identify opportunities for growth.
  

• Communicate department objectives, metrics, and quality standards.
  

• Supervise timely evaluation of complaints and returned products; initiate audits to ensure corrective actions are taken.
  

• Review and approve nonconformances, CAPAs, change controls, and QC investigations.
  

• Provide input to quality control reports, proposals, and business opportunities.
  

• Plan and oversee lab projects, including method transfer, optimization, and equipment qualification.
  

• Stay current with microbiological technology trends and regulatory requirements (FDA, HPRA, EMEA).
  

Requirements

Experience & Qualifications:

• Level 8 degree in Microbiology or related scientific discipline.
  

• Minimum 5 years’ experience in a QC Microbiology role, including at least 3 years in pharmaceuticals.
  

• 1–2 years in a supervisory or team lead role.
  

• Strong knowledge of microbiological testing techniques, including sterility testing, bioburden, endotoxin, environmental monitoring, autoclave, utilities testing, and gamma irradiation.
  

• Experience managing projects or leading teams.
  

• Familiarity with regulatory requirements for pharmaceutical and aseptic products.