Manufacturing Lead Downstream - Days

FUJIFILM Healthcare Americas Corporation; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Manufacturing Lead to drive manufacturing steps, enforce CGMP standards, and assist the supervisor. The role requires leading processes, performing in-process sampling, and mentoring junior staff in a 24/7 production setting.

The ideal candidate has a strong life-science background with 4+ years in CGMP manufacturing, plus hands-on experience with unit operations and safety procedures.

Qualifications

• Experience in CGMP manufacturing environments is required.
• Ability to execute, document, and validate manufacturing steps per SOPs and CGMP.
• Experience training and mentoring junior associates.

Responsibilities

• Adheres to safety protocols and promotes a culture of safety in manufacturing.
• Leads, executes, and documents manufacturing steps; monitors processes and controls SOPs/CGMP.
• Oversees in-process sampling and testing (pH, conductivity, visual inspection).
• Executes validation protocols and backs up supervisor/manager when needed.
• Trains and mentors junior staff; supports daily manufacturing scheduling.
• Leads troubleshooting and drives continuous improvement projects.
• Serves as functional lead for manufacturing execution and SME in two core areas.

Skills

Safety protocols

CGMP compliance

SOP adherence

Lead and back-up supervision

Process monitoring

In-process sampling

Mentoring juniors

Shift coordination

Continuous improvement

Education

High School Diploma/GED

Associate's degree in life science

Bachelor's degree in life science

Equivalent Military training or experience

Job description

The Manufacturing Lead executes and leads manufacturing processing steps, associated activities, and assists the supervisor/manager, as needed. The Lead adheres to and helps ensures all activities performed within the designed shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

Company Overview

At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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

Responsibilities

Job Description

• Adheres to strict safety protocols and contributes to building a culture of safety within the manufacturing environment
• Leads, executes, and documents manufacturing processing steps or support activities, process monitoring and control within a functional area, ensuring compliance with standard operating procedures (SOPs) and Current Good Manufacturing Practice (CGMP) regulations
• Oversees, leads, or performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to CGMP SOPs and provides approval as a back-up for the supervisor/manager, as needed
• Trains and mentors junior associates to enhance team capabilities
• Supports scheduling daily activities on the manufacturing floor and serves as a back-up for the supervisor, as needed
• Leads troubleshooting for operational issues
• Assists the supervisor with shift huddles and tier escalations, investigations, and continuous improvement projects
• Serves as the functional lead for manufacturing execution responsibilities
• Contributes to manufacturing continuous improvement efforts
• Serves as the subject matter expert (SME) in at least two core responsibilities for manufacturing assigned area
• Maintains training to perform all required activities
• Performs other duties, assigned

Requirements

• High School Diploma/GED with 8+ years of experience in a CGMP manufacturing environment; or
• Associate's degree in life science with 6+ years of experience in a CGMP manufacturing environment; or
• Bachelor's degree in life science with 4+ years of experience in a CGMP environment; or
• Equivalent Military training or experience

Preferred Requirements

• Experience with multiple unit operation (e.g., Chromatography, UFDF, etc.) and fully qualified in at least one functional area

Physical Demands

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Will work in environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions

Environmental Conditions

• Will work in warm/cold environments (0-100F).

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]).