CGMP Manufacturing Lead | 24/7 Operations

Merck & Co.; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a Manufacturing Lead to execute and oversee manufacturing processing steps, ensure CGMP compliance, and support the supervisor in a 24/7 facility. The role requires flexibility with shift rotation.

You will lead, document, monitor processes, train junior staff, and contribute to continuous improvement. This position offers growth in a fast-paced biopharma environment near RTP/Morrisville.

Qualifications

• High School Diploma or equivalent with 8+ years in a CGMP manufacturing environment;
• Associate's degree in life sciences with 6+ years in CGMP manufacturing;
• Bachelor's degree in life sciences with 4+ years in CGMP environment;
• Equivalent Military training or experience

Responsibilities

• Adheres to safety protocols and contributes to a culture of safety on the manufacturing floor.
• Leads, executes, and documents manufacturing steps with SOPs and CGMP compliance.
• Oversees in-process sampling and testing (e.g., pH, conductivity, visual inspection).
• Executes validation protocols and acts as back-up for supervisor/manager as needed.
• Trains and mentors junior associates to enhance team capabilities.
• Supports scheduling daily activities on the manufacturing floor and backs up the supervisor as needed.
• Leads troubleshooting for operational issues.
• Assists supervisor with shift huddles, tier escalations, investigations, and continuous improvement projects.
• Serves as the functional lead for manufacturing execution.
• Contributes to manufacturing continuous improvement efforts.
• Serves as SME in at least two core responsibilities for the assigned area.
• Maintains training to perform all required activities.
• Performs other duties, assigned.

Skills

CGMP compliance

Safety culture

Process monitoring

Documentation

Training mentoring

Team leadership

Education

High School Diploma

Associate's degree in life science

Bachelor's degree in life science

Equivalent Military training

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a Manufacturing Lead to execute and oversee manufacturing processing steps, ensure CGMP compliance, and support the supervisor in a 24/7 facility. The role requires flexibility with shift rotation.

You will lead, document, monitor processes, train junior staff, and contribute to continuous improvement. This position offers growth in a fast-paced biopharma environment near RTP/Morrisville.