Manufacturing Associate 4 (Downstream) - Day Shift (2-2-3)

About the role

We are seeking a Manufacturing Associate 4 to join our team at FUJIFILM Biotechnologies. This senior role involves leading and executing manufacturing processing activities in a cGMP environment, supporting both project-phase readiness and steady-state operations.

Responsibilities

• Contribute to operational readiness for bulk drug substance manufacturing during the project phase.
• Support procedure review/creation and development or transfer of manufacturing business processes.
• Provide testing and commissioning support for equipment/systems; travel up to 0–25% (domestic or international) may be required during the project phase.
• Lead, execute, and document manufacturing processing steps and support activities; perform process monitoring and control per cGMP standards.
• Perform in-process testing (e.g., pH, conductivity, visual inspection).
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs).
• Maintain required training and qualifications for all assigned activities.
• Aid and/or lead cycle counts and manage materials for the assigned manufacturing area.
• Support and/or assist senior-level associates or the supervisor with scheduling daily activities on the manufacturing floor, as needed.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Requirements

• High School Diploma or GED and 6+ years of experience in life sciences manufacturing; or Associate degree and 4+ years of experience in life sciences manufacturing; or BA/BS and 2+ years of experience in life sciences manufacturing; or Equivalent military training/experience.
• Advanced understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures; strong troubleshooting ability.
• Demonstrated expertise with operation of specific production equipment.
• Ability to follow technical instructions, execute operations, and document accurately.
• Strong verbal and written communication; effective team collaboration skills.
• Strong time management; ability to adapt in a fast-paced, changing environment.
• Willingness to work shifts (including weekends/nights) and travel up to 0–25% as needed.

Qualifications

• BioWorks or BTEC Capstone cGMP coursework preferred.

Physical Requirements

The physical demands described here are representative of those that may be required to successfully perform essential job functions in a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!