Job Details
Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US
About This Role
This role as Manufacturing Dssociate 3 in Drug Product, will mainly include the operation of the filling line including all the related tasks. This role will support projects, which will influence the manufacturing processes for Drug Product Manufacturing. This includes, training new colleagues, maintaining compliance of cGMP documents and assisting in the qualification of equipment as well as all other aspects of the 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.
While in project phase, the schedule will be Monday-Friday during normal business hours. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition.
During the project phase
- Contribute to the preparation for operational readiness related to bulk drug product manufacturing
- Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes and 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 as well as 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
Who You Are
You have the ability to assist in troubleshooting. You have strong verbal and written communication skills. You have knowledge of the operation of production equipment in their respective unit operation. You have a basic understanding of manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have the ability to work in a team environment.
Basic Requirements
- High School Diploma or GED with 4 years of direct experience in a cGMP manufacturing environment
Preferred Requirements
- Associate s Degree + 2 Years of Direct Experience in a cGMP manufacturing environment OR
- BA/BS, preferably Life Sciences or Engineering
- 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
- Be exposed to noisy environments
- Have a normal range of vision
- Climb ladders and stairs of various heights
- Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours
- Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required
- May be required to lift up to 50 pounds on occasion
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email
...@fujifilm.com
. 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.
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection No x Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No x Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No x Yes
Ability to discern audible cues. No x Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. x No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No x Yes
Ability to stand for prolonged periods of time. No x Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. No x Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No x Yes
Ability to operate machinery and/or power tools. x No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. x 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions. No x Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments x No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. x No Yes
Will work in small and/or enclosed spaces. x No Yes
Will work in heights greater than 4 feet. No x Yes