Manufacturing Associate 3 – Drug Product Formulation Position Available In Wake, North Carolina

Tallo's Job Summary: The Manufacturing Associate 3 in Drug Product Formulation at FUJIFILM Diosynth Biotechnologies in Holly Springs, NC, supports drug product manufacturing, operates filling lines, ensures cGMP compliance, and assists in facility startup. This role requires flexibility with working hours, shift rotation, and may involve travel during project phases. Basic requirements include a high school diploma and 4 years of cGMP manufacturing experience. Other requirements include specific educational backgrounds or equivalent military training.

Company:
Fujifilm
Salary:
JobFull-timeOnsite

Job Description

Position Overview The Manufacturing Associate 3, in Drug product is responsible for the operation of the filling lines including all the related tasks. This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. Company Overview

FUJIFILM

Diosynth 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 Contribute to the preparation for operational readiness related to bulk drug substance manufacturing Possible assignments include supporting projects related to procedure review and/or creation, development or transfer of manufacturing businessprocesses, testing and commissioning support Travel up to 0‐25% (international or domestic) may be required during the project phase In Operations Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control. Perform in‐process testing (pH, conductivity, visual inspection) Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) Maintain training to perform all required manufacturing activities Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area Perform Operations for all aspects of filling line Assist the lead with tasks in manufacturing activities Assist with the coordination of daily shift activities This role requires shift work (weekend and potential for nights) Perform other duties as assigned Basic Requirements High school diploma or GED 4 years of direct experience in cGMP manufacturing environment Preferred Requirements Associate’s Degree + 2 years direct experience in cGMP manufacturing environment OR BA / BS, preferably Life Sciences or Engineering OR Equivalent Military training or experience Qualified Experience on unit operation (DPFG Filler or Cell Culture – Seed Train) BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Be exposed to an environment that may necessitate respiratory protection May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program Will work in environment operating a motor vehicle or Powered Industrial Truck Ability to discern audible cues Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color 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 operate machinery and/or power tools 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 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 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 (FDBN_PNC@fujifilm.com).

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