Manager, Quality Control & Analytical Development
About the role
Oath is a leading microbial sciences company that utilizes natural soil biology to offer innovative solutions to the climate crisis and sustainable agriculture. The role involves managing QC and analytical assay development for Oath’s live microbial products.
Key Responsibilities
Own QC review and release of production batches against established specifications.
Define and maintain product specifications, release criteria, sampling plans, and QC testing requirements.
Review QC data, batch records, COAs/COCs, and supporting documentation.
Lead investigations of deviations, out-of-specification results, and product quality issues.
Establish stability and shelf-life testing and monitor product quality trends.
Develop, optimize, and validate quantitative assays supporting manufacturing, QC, and product release.
Apply techniques including CFU methods, qPCR/qRT-PCR, flow cytometry, sequencing, and other relevant analytical methods.
Ensure assays are reproducible, scalable, and fit for manufacturing routine QC use.
Lead transfer and implementation of QC methods at CROs and CMOs/CDMOs.
Define testing requirements and ensure consistent execution of Oath methods and specifications.
Review external QC data, batch documentation, and technical reports.
Partner with manufacturing teams to troubleshoot quality issues and improve QC processes.
Develop and maintain QC SOPs, analytical methods, specifications, protocols, and reports.
Establish appropriate sample tracking, data management, and QC documentation practices.
Cross-functionally collaborate with Production, Bioprocess Development, R&D, Regulatory, Supply Chain, and Field Science.
Provide data-driven recommendations on product quality, manufacturing, formulation, and stability.
As the team grows, mentor and manage scientists and research associates.
Qualifications
PhD or MS in Microbiology, Biotechnology, Analytical Sciences, Fermentation Science, or a related field, with relevant industry experience.
Experience with QC testing, product specifications, method validation, and production batch review/release.
Experience developing and validating quantitative assays for microbial, biological, or fermentation-based products.
Experience working with manufacturing teams, CROs, CMOs/CDMOs, or external testing laboratories.
Strong ownership, communication, documentation, and cross-functional leadership skills.
Preferred Experience:
Experience in agriculture, agricultural biotechnology, biologicals, or microbial products.
Experience with deviations, OOS investigations, stability programs, and quality systems.
Job Type: Full-time, non-exempt position in the United States.
Compensation: $100,000 - $130,000