Role Summary
Sr. Manager, Manufacturing Sciences & Technology (MSAT) based in Redwood City, CA. Leads tech transfer of enzyme manufacturing processes into internal manufacturing suites and external partner facilities, provides technical leadership across the product lifecycle, and drives scale-up and continuous process improvements to enhance yield, robustness, and critical quality attributes. The role may be on-site, remote, or hybrid depending on company arrangements.
Responsibilities
- Lead the tech transfer of enzyme manufacturing processes into internal manufacturing suites and external partner facilities.
- Provide technical leadership across the product lifecycle, including process fit-to-plant assessments and manufacturability risk scoring.
- Drive scale-up activities and continuous process improvements to enhance yield, robustness, and maintain critical quality attributes.
- Serve as a subject matter expert to internal teams and CDMOs during process design, change control, and technical strategy execution.
- Provide on-the-floor technical support during critical manufacturing operations, including first-in-series runs.
- Oversee batch execution and support disposition activities ensuring compliance with ISO requirements.
- Lead real-time troubleshooting for equipment and process deviations to minimize downtime and ensure production continuity.
Qualifications
- Experience with E. coliβbased protein expression and purification.
- Prior involvement with CDMOs, including tech transfer and manufacturing oversight.
- Experience supporting clinical or commercial manufacturing deviation closures and regulatory submissions.
- Familiarity with enzyme manufacturing platforms or biologics CMC activities.