Quality Leader - Microbiology

Verdesian Asia•Cape Girardeau, MO

2d•Onsite

About The Position

This role is responsible for establishing and leading the microbiology laboratory and quality control functions for biological products. The Quality Leader will design, build, and operate an on-site microbiology lab, define quality control processes for raw materials and finished goods, provide quality leadership on the production floor, implement contamination control strategies, develop training programs, and lead investigations and continuous improvement initiatives. The position requires a strong technical background in microbiology, hands-on experience in a manufacturing environment, and the ability to influence and drive quality culture.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.