Downstream Supervisor (Biologics)

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a shift leader to supervise a manufacturing team responsible for bulk drug substance production in a 24/7 operation with flexible hours during the project phases.

In the Operations Phase starting mid-2025, you will coordinate daily shift assignments, lead huddles, maintain a safe and compliant environment, drive continuous improvement projects, and partner with maintenance, calibration, and other functional areas to optimize

Qualifications

• High school diploma or GED with 8 years pharma/biotech experience.
• Bachelor's or higher in Life Sciences with 4+ years in pharma/biotech operations or projects.
• Associates degree with 6+ years in pharma/biotech operations or projects.
• Military experience equivalent to life sciences background considered.
• Experience manufacturing biological products and familiarity with GMP/GLP requirements.
• Previous experience leading, supervising or managing others.

Responsibilities

• Oversee shift team of manufacturing associates on technical and operational topics.
• Support FAT/IV/OV/PQ testing and documentation review and onboarding.
• Ensure training is up-to-date and enforce company policies (time, travel, time off).
• Coordinate daily shift assignments and lead daily huddles to meet production schedules.
• Maintain a safe, cGMP-compliant environment; support investigations and continuous improvements.
• Coordinate with maintenance, calibration and other functions for space and equipment access.

Education

High School Diploma or GED

BA/BS Degree in Life Sciences

Associates Degree in Life Sciences

Military Experience

GMP/GLP experience

Job description

Position Overview

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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

Project Phase (Through Mid-2025)

• Supports Factory Acceptance Testing (FAT) at the vendor site as required
• Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
• Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management
• Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment
• Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees

Operations Phase (Starting Mid-2025)

• Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
• Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
• Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports
• Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
• Supports manufacturing investigations and continuous improvement projects
• Coordinates with other functional areas for additional activities requiring access to the manufacturing space & equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment
• Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
• Performs other job as assigned

Basic Requirements

• High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects

Preferred Requirements

• BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projectsOR
• Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projectsOR
• Military Experience of equivalence
• Experience in manufacturing of biological products, familiar with GMP/GLP requirements
• Previous experience leading, supervising or managing others

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Will work in an environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation program
• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

ENVIRONMENTAL CONDITIONS

• Will work in heights greater than 4 feet

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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]).