Manufacturing Associate 2, Drug Product

Position Overview

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

 

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. 

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

 

Job Description

What You'll Do

 

During the Project Phase:

 

• Contributes to the preparation for operational readiness related to drug product manufacturing

• Possible assignments include supporting projects related to, procedure review and/or creation, development or transfer of manufacturing business

processes, testing and commissioning support

• Travel up to 0-25% (international or domestic) may be required

 

In Operations:

 

• Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control

• Performs in-process testing (pH, conductivity, visual inspection)

• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)

• Maintains training to perform all required activities

• After startup this role requires shift work (weekend and potential for nights)

•Performs other duties as assigned 

 

Basic Requirements

 

• High School Diploma or GED with 2 years of related experience

 

Preferred Requirements

 

• Associate’s Degree, preferably in Life Science’s or similar
• 2 Years + Direct experience in a cGMP manufacturing environment
• BioWorks or BTEC Capstone cGMP coursework preferred

 

 

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

 

• Be exposed to an environment that may necessitate respiratory protection
• My work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Ability to discern audible cues
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• 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 33 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 FDBN_PNC@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 i