Lead Microbiologist

Key Responsibilities

• Process Ownership & Fermentation Leadership
• Own fermentation performance across products, including troubleshooting, process optimization, and consistency of outcomes.
• Design and lead experiments to improve product yield, consistency, and process efficiency.
• Track, investigate, and resolve process deviations, ensuring proper documentation and follow-up actions.
• Microbiology & Quality Systems
• Design, validate, and improve microbial testing protocols, including CFU quantification, cell identification, and contamination control strategies.
• Oversee aseptic technique training and ensure consistent application across all production activities.
• Audit production processes and operator execution to ensure compliance with SOPs and microbiological best practices.
• Maintain ownership of microbial quality within production, partnering closely with Quality Control to ensure accurate and reliable testing.
• Support and help define quality standards for products, including agricultural product lines.
• Lead quality-focused activities in the production and warehouse environment, including verification of fill volumes, product handling, and storage practices.

Qualifications & Requirements

• Bachelor's degree in Microbiology, Biology, or related scientific field required.
• 5-8+ years of progressive experience in Microbiology, Fermentation, or biomanufacturing environments.
• Deep technical expertise in fermentation processes and scale-up, aseptic technique and contamination prevention, microbial testing methods (CFU quantification, organism identification).
• Demonstrated experience leading complex troubleshooting efforts and implementing permanent process or equipment solutions.
• Proven ability to design, validate, and improve microbiological testing protocols and production processes.
• Strong data analysis skills with the ability to interpret trends and drive data-based decisions.
• Advanced experience with SOP and batch record development, revision, and compliance oversight.
• Experience leading or supporting audits, ensuring documentation accuracy, and maintaining regulatory readiness.
• Strong cross-functional collaboration experience with R&D, Quality, and Operations teams.
• Demonstrated ability to develop and deliver training programs and mentor technical staff.
• Advanced ERP(Netsuite or similar) experience, including BOM review, inventory management, and production planning support.
• Experience in a pilot-scale or commercial biomanufacturing environment preferred.
• Prior informal or formal leadership responsibility such a project leadership, team mentorship, or process ownership a plus.