Manufacturing Readiness Lead, Tech Transfer

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Tech Transfer to lead operational readiness, drive troubleshooting, and keep 24/7 production running safely and compliantly.

The role collaborates with operations, quality, engineering, and maintenance to develop methods, document changes, and support tech transfer while upholding rigorous GMP standards.

Qualifications

• Experience in manufacturing operations and GMP environments.
• Ability to troubleshoot complex process issues and implement effective corrective actions.
• Experience creating/managing manufacturing documentation, SOPs, and change controls.

Responsibilities

• Lead operational readiness during project phases and establish methods, procedures, and readiness criteria for new or modified processes.
• Serve as a process SME; lead troubleshooting and communicate risks for high-severity events.
• Coordinate and optimize batch planning; align with preventive maintenance to minimize downtime and ensure equipment readiness.
• Own and improve documentation; create/update SOPs, batch records, and work instructions under change control.
• Enable training and onboarding; develop and manage curricula for operational capability.
• Manage non-batch activities like changeovers and PM documentation.
• Support technology transfer; contribute to process mapping and acceptance criteria.
• Drive quality and CI initiatives; support CAPAs and continuous improvement projects.
• Support audits and inspections with evidence and responses; implement sustainable actions.
• Collaborate with cross-functional teams and operate independently on new assignments.

Skills

Manufacturing operations

Troubleshooting

Batch planning

Documentation

Training/onboarding

Cross-functional collaboration

Safety/compliance

Education

BS/BA in life sciences or engineering

Associate degree

Equivalent military experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Tech Transfer to lead operational readiness, drive troubleshooting, and keep 24/7 production running safely and compliantly.

The role collaborates with operations, quality, engineering, and maintenance to develop methods, document changes, and support tech transfer while upholding rigorous GMP standards.