Position SummaryWe are seeking an experienced Manager, Quality Control & Analytical Development to lead QC and analytical assay development for Oath's live microbial products. This role will own QC methods, specifications, and production batch review and release, while developing and validating fit-for-purpose assays to support manufacturing and product quality. You will ensure microbial products meet quality requirements throughout cultivation, fermentation, downstream processing, formulation, and storage, and translate analytical methods into robust, scalable QC tools for internal and external manufacturing.
Key ResponsibilitiesQuality Control & Batch Release- 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.
Analytical Assay Development & Validation- Develop, optimize, and validate quantitative assays supporting manufacturing, QC, and product release.
- Establish robust methods for microbial titer, viability, sporulation, purity, stability, and other key quality attributes.
- 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.
Manufacturing & Method Transfer- 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.
Quality Systems & Documentation- Develop and maintain QC SOPs, analytical methods, specifications, protocols, and reports.
- Establish appropriate sample tracking, data management, and QC documentation practices.
Cross-Functional Collaboration- Partner closely 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.
QualificationsRequired- 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 in agriculture, agricultural biotechnology, biologicals, or microbial products strongly preferred.
- Experience with deviations, OOS investigations, stability programs, and quality systems preferred.
Job Type: Full-time, non-exempt position in the United States. At this time, Oath, Inc. is not able to provide visa sponsorship or work authorization support.
Location: Vacaville, CA, 3 days a week with international travel to Europe up to 20%
Compensation: $100,000 - $130,000
