Sr Manufacturing Project Lead

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

 

The Senior Manufacturing Project Lead will lead and organize manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. 

 

What You’ll Do

 

During the Project Phase:

• Leads operational readiness initiatives as well as site commissioning and qualification efforts
• Manages cost and schedule execution of project delivery items and manufacturing operational projects
• Supports organization and development of operational readiness 

In Operations:

• Leads manufacturing focused projects at the request of leadership
• Actively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects, as assigned
• Supports materials management within manufacturing
• Drives column packing and changeover activities including the generation of documents
• Leads manufacturing support items which could include, but not limited to:

• • Manufacturing change controls and corrective and preventive actions (CAPAs)
  • Short flow investigations and alert/action limits
  • Finite manufacturing schedules
  • Continuous improvement, escalation, and mitigation of manufacturing issues
  • Cross site or local manufacturing projects
  • Technology transfer manufacturing deliverables
  • Assist in regulatory inspections and audits
  • Perform other duties as assigned.

Who You Are

 

You have strong verbal and written communication skills. You have strong time management skills. You have the ability to adapt in a fast-paced environment, pivot and adjust plans accordingly. You have the ability to think critically and have superior problem-solving skills. You have a team-based attitude and ability to work in a global team environment, build relationships and communicate effectively with others.  

 

Basic Requirements

• High School Diploma or GED
• 12 years of related experience

Preferred Requirements

• Associate’s Degree in Life Sciences or Engineering + 10 years of direct experience OR
• Bachelor’s degree in life sciences or engineering + 8 years of direct experience OR
• Equivalent Military experience/training
• Previous experience in a cGMP manufacturing environment
• Relevant experience in CAPEX/OPEX projects
• Ability to lead teams, facilitate workshops and effectively communicate project status
• Experience in campaign lifecycle activities
• Understanding of manufacturing equipment, operations, and cadence
• BioWorks or BTEC Capstone cGMP coursework preferred  

 

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS  

• Ability to stand for prolonged periods of time.  
• Ability to sit for prolonged periods of time.   
• Ability to conduct activities using