Manufacturing Associate 3 - Drug Product

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