Quality Control & Analytical Development Manager

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

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