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 frameworks for biological agricultural products in the U.S. and export markets
- Experience training non-technical personnel in microbiology and contamination control principles
Skills & Leadership Attributes- Highly hands-on and action-oriented; comfortable operating in both lab and production environments
- Strong technical expertise paired with practical, operational decision-making ability
- Effective communicator across all levels of the organization-from operators to senior leadership
- Builder mindset with a passion for establishing new systems and capabilities
- Ability to influence and lead cultural changes in a transitioning manufacturing environment
- Credible, trusted technical leader and advocate for microbiological quality on site
Physical Demands:The physical demands described here are the representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk; and stoop, kneel, crouch or crawl. The employee must regularly lift and/or move up to ten pounds, occasionally lift and/or move up to twenty pounds, and rarely lift and/or move more than twenty-five pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
