Quality Leader - Microbiology

Key Responsibilities

• Microbiology Laboratory Development & Operations
• • Design, build, and commission an on-site microbiology laboratory aligned with business and operational needs
  • Define laboratory scope, capabilities, layout, and workflows in collaboration with Operations and Engineering
  • Specify, procure, and install required equipment (e.g., biosafety cabinets, autoclaves, incubators, analytical instruments)
  • Establish equipment maintenance, calibration, and validation programs
  • Develop and validate analytical methods, including CFU enumeration, viability, purity, and contamination testing
  • Implement biosafety, sample handling, and waste management protocols
  • Manage daily laboratory operations and supervise laboratory personnel as the team grows
  • Establish material and supply management processes for laboratory operations
• Biological Product Quality Control

• • Establish specifications, testing protocols, and release criteria for raw materials, in-process samples, and finished goods
  • Lead supplier quality engagement for biological inputs, including peat carriers and microorganism cultures
  • Oversee cold storage systems to ensure product viability, traceability, and integrity
  • Own and execute final product release decisions for ST&I biological products
• Production Floor Quality Leadership

• • Maintain a strong and consistent presence on the production floor, working directly with operators and supervisors
  • Identify contamination risks and quality gaps in real-time operations and drive immediate corrective actions
  • Lead resolution of current and emerging product quality issues, including contamination and product integrity concerns
  • Partner with Production to optimize batch sequencing, changeovers, and material flow to minimize cross-contamination risk
  • Develop and manage a retention sample program to support product investigations and customer concerns
    
    
• Contamination Control & Environmental Monitoring

• • Design and implement an environmental monitoring program across production, laboratory, warehouse, and packaging areas
  • Establish sanitation programs and cleaning validation processes appropriate for biological manufacturing
  • Develop and enforce changeover, segregation, and contamination control procedures across product lines
    
    
• Training & Site Capability Development

• • Train operators, warehouse personnel, and site leadership on microbiology fundamentals, aseptic technique, and contamination prevention
  • Build organizational awareness and capability in biological product handling and quality
  • Develop practical SOPs, work instructions, and training materials tailored for operational use
  • Serve as the site’s subject matter expert (SME) for microbiology and biological systems
    
    
• Investigations, CAPA & Continuous Improvement

• • Lead microbiological investigations from initial observation through root cause analysis and corrective action implementation
  • Establish and drive CAPA processes appropriate for biological risk and variability
  • Track and report key quality metrics, including contamination rates, product release timelines, complaints, and CAPA effectiveness
  • Support customer interactions, audits, and regulatory inspections as the technical microbiology lead

Required Qualifications

• Bachelor’s degree in microbiology, Industrial Microbiology, Microbial Biotechnology, or related field (Master’s preferred)
• Hands-on experience working with live microorganisms in a manufacturing or industrial environment (e.g., inoculants, fermentation, food, biologics)
• Demonstrated experience designing, commissioning, or significantly upgrading a microbiology laboratory
• Proven expertise in microbiological quality control, including aseptic technique, environmental monitoring, and contamination control
• Experience leading investigations and CAPA processes for biological or microbiological issues
• Operational leadership experience in a manufacturing environment with strong floor engagement
  
  

Preferred Qualifications

• Experience with agricultural microorganisms (e.g., rhizobia, Bacillus, Trichoderma, mycorrhizae, Azospirillum)
• Experience with dry and liquid carrier systems, including peat-based inoculants
• Familiarity with regulatory fr