Manufacturing Operations Excellence Lead

Oath; Vacaville (CA); Hybrid; USD 140,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Stock options

Job summary

Oath, a leading microbial sciences company, seeks a Senior Manager of Manufacturing Operations in Vacaville, CA. The role oversees SOPs, specifications, batch records, and release processes, coordinating with production, QA, supply chain, regulatory, and external partners to ensure scalable, compliant manufacturing.

You will build systems and standards across internal and external manufacturing partners, drive change control, and report KPIs to improve yield, quality, and throughput.

Qualifications

• BS or MS in biotechnology, biochemical engineering, chemical engineering, microbiology, or related discipline.
• 7+ years in biotechnology/biomanufacturing or related setting.
• Experience with manufacturing documentation and controlled processes.
• Experience working with external manufacturers or CDMOs a plus.

Responsibilities

• Develop and maintain manufacturing SOPs, work instructions, specifications, and process documentation.
• Establish and maintain product and raw material specifications and associated documentation.
• Coordinate preparation and maintenance of SDSs, COAs, COCs, batch records, and release documentation.
• Support QC and batch release processes, ensuring required testing and documentation are completed prior to release.
• Drive manufacturing change control and process change management.
• Coordinate activities across manufacturing, quality, regulatory, supply chain, shipping, and planning.
• Support technology transfer and operational readiness with external manufacturing partners and CDMOs.
• Establish, track, and report manufacturing KPIs, including yield, success rate, quality, throughput, and operational performance.
• Identify operational gaps and implement systems and processes that improve manufacturing reliability and scalability.
• Audit Oath vendors for compliance with process and procedures

Skills

Biotech manufacturing

SOP development

Documentation control

Cross-functional collaboration

Vendor management

Education

BS/MS in biotechnology or related

Tools

Excel

Google Suite

Slack

Job description

Oath, a leading microbial sciences company, seeks a Senior Manager of Manufacturing Operations in Vacaville, CA. The role oversees SOPs, specifications, batch records, and release processes, coordinating with production, QA, supply chain, regulatory, and external partners to ensure scalable, compliant manufacturing.

You will build systems and standards across internal and external manufacturing partners, drive change control, and report KPIs to improve yield, quality, and throughput.