Manufacturing Associate 5 - Column Packing

About the role

Join a high-growth biologics manufacturing team that’s bringing lifesaving therapies from concept to clinic. As a Senior Manufacturing Associate, you’ll lead day-to-day operations on a 24/7 manufacturing floor and play a hands-on role in getting our new facility fully operational.

Responsibilities

• Serve as a key contributor for operational readiness in bulk drug substance manufacturing.
• Support commissioning and qualification of equipment.
• Create and/or review procedures and SOPs.
• Help onboard manufacturing staff and transfer or develop manufacturing business processes.
• Support new item creation and single-use assembly transfer or design.
• Champion a strong safety culture and strictly follow EHS protocols.
• Lead, execute, and document manufacturing processing steps and support activities within your functional area, ensuring adherence to SOPs and cGMP regulations.
• Maintain all required training and qualifications; train and mentor junior associates to elevate team capabilities.
• Support daily floor scheduling and act as a backup to the supervisor as needed.
• Lead troubleshooting for operational issues to restore steady-state production.
• Assist the supervisor with shift huddles, tiered escalations, investigations, and continuous improvement projects.
• Perform other duties as assigned to meet production goals.

Requirements

• High school diploma or GED with 8 years of experience in life sciences manufacturing, OR Associate degree with 6 years of experience in life sciences manufacturing, OR BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing, OR Equivalent military experience.
• Proficient understanding of cGMP regulations and pharmaceutical industry standards.
• Fully qualified in a functional area (e.g., Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture, or Purification) and subject-matter expertise across all unit operations within that area (e.g., Inoculation, Seed Train, Production Bioreactor).
• Preferred Bioworks Certification.

Qualifications

• Minimum Education And Experience (one Of The Following): High school diploma or GED with 8 years of experience in life sciences manufacturing, OR Associate degree with 6 years of experience in life sciences manufacturing, OR BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing, OR Equivalent military experience.

Skills

• Comprehensive knowledge of cGMP regulations and pharmaceutical industry standards.
• Strong problem-solving and troubleshooting skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong organizational and time management skills.

Benefits

Our company offers a dynamic work environment and cultivates a culture that fuels your purpose, energy, and drive—what we call Genki. We are committed to providing equal opportunities in hiring, promotion, and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

Pay

Competitive salary based on experience and qualifications.

Schedule

24/7 rotating shifts.

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.

Location

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Company Culture

We are guided and united by our Group Purpose of "giving our world more smiles." 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.

Equal Opportunity Employer

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).