Manufacturing Supervisor, Downstream

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Upstream Supervisor to lead a manufacturing team across startup and GMP runs. You will guide commissioning, qualification, and operational readiness, while building processes for first GMP batches this year.

Relocation assistance is available. The role requires strong leadership, GMP/GLP familiarity, and a focus on safety and quality as the site scales with large-scale bioproduction.

Qualifications

• High School Diploma or GED with 8 years of experience in large pharma/biotech operations or projects.
• BA/BS Degree in Life Sciences with 4+ years in similar role in pharma/biotech operations or projects OR Associates with 6+ years.

Responsibilities

• Provide on-the-floor leadership for a shift team of up to 7-10 manufacturing associates.
• Coordinate daily shift assignments and lead daily huddles to manage the schedule.
• Mentor and develop team members and ensure cGMP training is up to date.

Skills

Leadership

Team supervision

Commissioning/Qualification

Education

High School Diploma or GED

BA/BS Degree in Life Sciences

Associates Degree in Life Sciences

Job description

Position Overview

As an upstream supervisor, you'll lead and inspire a team of manufacturing associates, supporting the start up of a new large scale cell culture facility. The Upstream area includes: An inoculum lab, two seed reactor trains (each with 4 reactors of increasing size), four 20,000L production reactors, a harvest suite, media preparation, and parts prep area.

You and your team will work a 2-2-3, 12 hour shift schedule to support the ongoing activities in these areas.

You'll start out leading a team in project phase supporting commissioning and qualification efforts in addition to helping prepare the facility to be operational ready. It's an exciting opportunity to help build out processes and procedures in preparation of the first GMP run later this year.

Relocation Assistance Available

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 Q3 2025)

• Supports various commissioning and qualification activities
• Lead and support your team in operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management
• Responsible for building and executing a training plan for your team to prepare for the first GMP batches later this year
• Mentoring and developing team members
• Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees
• Collaborate and coordinate cross functionally with various support groups as needed in support of start up activities

Operations Phase (Starting Q3 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 focusing on the development and success of your team
• Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training, performing gemba walks, and having a safety and quality mindset culture within your team
• Supports manufacturing investigations and continuous improvement projects
• Coordinates with other functional areas for additional activities requiring access to the manufacturing space and 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

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 projects OR
• Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects OR
• 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

EEO Information

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 ([e-mail]).