Manufacturing Lead Upstream

Fujifilm•Morrisville, NC

5d•Onsite

About The Position

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

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

Nice To Haves

Experience with multiple unit operation (e.g., Cell Culture, Fermentation, etc.) and fully qualified in at least one functional area

Responsibilities

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