Manufacturing Associate 5 - Column Packing

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Manufacturing Associate to lead day‑to‑day operations on a 24/7 manufacturing floor and drive readiness for a new facility.

You will coach teammates, ensure cGMP compliance, supervise processing steps, and collaborate across functions to scale up drug substance production. This role offers hands‑on problem solving, extensive training, and an opportunity to help bring lifesaving therapies from concept to clinic.

Qualifications

• Minimum education and experience as stated: HS + 8 yrs life sciences manufacturing, or Associate +6 yrs, or BA/BS +4 yrs, or equivalent military experience.
• Proficiency in cGMP regulations and pharmaceutical standards.
• Functional area qualification with cross‑unit expertise across all operations.

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 follow EHS protocols.
• Lead, execute, and document manufacturing steps and support activities, ensuring SOPs and cGMP adherence.
• Monitor and control processes, perform in‑process testing as needed.
• Execute validation protocols per cGMP SOPs and provide approvals as backup.

Skills

cGMP knowledge

Team leadership

Troubleshooting

Documentation

Training & mentoring

Process monitoring

Education

High school diploma or GED

Associate degree

BA/BS in Life Sciences or Engineering

Equivalent military experience

Job description

Position Overview

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. If you love cGMP precision, coaching teammates, and solving problems on the fly, this is your next move.

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!

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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What you’ll do

During the project phase, you will:

• 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.

In routine operations, you will:

• 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.


• Monitor and control processes, performing and/or overseeing in‑process testing (pH, conductivity, visual inspections).


• Execute validation protocols per cGMP SOPs and provide approvals as a backup to the supervisor.


• Maintain all required training and qualifications; train and mentor junior associates to elevate team capabilities.


• Support daily floor scheduling and act as a back‑up 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.


• Serve as area lead for cycle counts and materials management.


• Perform other duties as assigned to meet production goals.

What you bring

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.

Plus:

• 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.

Why you’ll love it here

• Make a direct impact on patients by ensuring reliable, compliant manufacturing of critical therapies.


• Work with state‑of‑the‑art technologies and single‑use systems in a collaborative, safety‑first environment.


• Grow your leadership skills by mentoring others and acting as a back‑up to the supervisor.

EEO Information

Fujifilm is committedto 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 ([e-mail]).