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/or 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 manufacturing activities.
• Assist 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.
• High level of knowledge and expertise operating specific production equipment.
• Strong troubleshooting ability; ability to follow technical instructions and document accurately.
• Strong verbal and written communication; effective team collaboration skills.
• Strong time management; ability to adapt in a fast-paced, changing environment and pivot as needed.
• Willingness to work shifts (including weekends/nights); travel up to 0–25% during the project phase as needed.

Qualifications

• Advanced understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures.
• High level of knowledge and expertise operating specific production equipment.
• Strong troubleshooting ability; ability to follow technical instructions and document accurately.
• Strong verbal and written communication; effective team collaboration skills.
• Strong time management; ability to adapt in a fast-paced, changing environment and pivot as needed.
• Willingness to work shifts (including weekends/nights); travel up to 0–25% during the project phase as needed.