CGMP Manufacturing Lead & Process Mentor

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Manufacturing Lead to execute and oversee manufacturing steps, ensuring CGMP and safety standards are met. The role supports a 24/7 operation with shift flexibility and provides back-up to the supervisor as needed.

You will lead processing, sampling, testing, and troubleshooting, while mentoring junior staff and driving continuous improvement in a fast-paced biopharma manufacturing site near RTP.

Qualifications

• CGMP manufacturing experience required.
• Strong leadership and mentoring capabilities.
• Experience with process monitoring and control.
• Familiarity with SOPs and CGMP regulations.

Responsibilities

• Adheres to safety protocols and fosters a safety culture on the manufacturing floor.
• Leads, executes, and documents processing steps, monitoring, and control within a functional area, ensuring SOP and CGMP compliance.
• Oversees in-process sampling and testing (e.g., pH, conductivity, visual inspection).
• Executes validation protocols according to CGMP SOPs and acts as back-up for supervisor/manager.
• Trains and mentors junior associates to enhance team capabilities.
• Supports scheduling daily activities on the manufacturing floor and serves as back-up for the supervisor.
• Leads troubleshooting for operational issues.
• Assists supervisor with shift huddles, escalations, investigations, and continuous improvement projects.
• Serves as the SME in at least two core responsibilities for the manufacturing area.
• Maintains training to perform all required activities.

Skills

CGMP manufacturing experience

Leadership

Training & mentoring

Process monitoring

Education

High School Diploma/GED

Associate’s degree in life science

Bachelor’s degree in life science

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Manufacturing Lead to execute and oversee manufacturing steps, ensuring CGMP and safety standards are met. The role supports a 24/7 operation with shift flexibility and provides back-up to the supervisor as needed.

You will lead processing, sampling, testing, and troubleshooting, while mentoring junior staff and driving continuous improvement in a fast-paced biopharma manufacturing site near RTP.