Manager, Quality Control & Analytical Development

Oath; Vacaville (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Oath is a leading microbial sciences company focused on live microbial products. We seek an experienced Manager, Quality Control & Analytical Development to own QC methods, specifications, and batch release, while developing robust analytical assays for manufacturing and product quality.

The role covers method transfer to CROs/CMOs, validation of QC tools, and leadership of a growing team. You will collaborate with Production, R&D, Regulatory, and Supply Chain to ensure product quality and

Qualifications

• PhD or MS in Microbiology, Biotechnology, Analytical Sciences, Fermentation Science, or related field with industry experience.
• Experience with QC testing, product specifications, method validation, and production batch review/release.
• Experience developing and validating quantitative assays for microbial or fermentation products.
• Experience with CROs/CMOs/CDMOs or external testing labs.
• Strong ownership, communication, documentation, and cross-functional leadership skills.

Responsibilities

• Own QC review and release of production batches against specifications.
• Define and maintain product specifications, release criteria, sampling plans, and QC testing requirements.
• Review QC data, batch records, COAs/COCs, and supporting docs.
• Lead investigations of deviations, OOS results, and product quality issues.
• Establish stability and shelf-life testing and monitor quality trends.

Skills

QC operations

Analytical development

Data analysis

Cross-functional leadership

Project management

Communication

Education

MS in Microbiology

PhD or related field

Tools

qPCR

Flow cytometry

Sequencing

Job description

Manager, Quality Control & Analytical Development

About Oath

Oath is a leading microbial sciences company that utilizes natural soil biology to offer innovative solutions to some of the most critical challenges facing our planet - the climate crisis and the shift to sustainable agriculture. We imagine a world where these crises are not just alleviated, but reversed, replenishing Earth's microbiomes.

Our solution has moved beyond the lab and into real-world deployment, focused on improving farmer livelihoods with teams in Rwanda, Europe, the United States, and expanding. When you join Oath, you become part of a collaborative network that prioritizes high quality scientific work. You will be working alongside trained scientists, talented commercial teams, and a broad network of partners—an ecosystem designed to help you do your best work and grow your capabilities.

Position Summary

We 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 Responsibilities

Quality 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.

Qualifications

Required

• 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

As set forth in Oath’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.