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.
About This Role Provide project management and communications support for key complex site projects that support the completion, start up, and operation of a greenfield Biotech Manufacturing facility. The focus for this position will be to establish, facilitate and deliver continuous improvement and risk management activities in support of the new site readiness for operations, start up and ongoing operations.
What You'll Do Continues the establishment and facilitation of operations readiness processes and project plans for site cGMP go live across the business functions and site buildings. Actively leverages best practices and maintain alignment with our sister site in Denmark. Establishes continuous improvement processes and risk management processes in support of site readiness, start up, and ongoing operations. Actively leverages best practices and maintain alignment with our sister site in Denmark. Partners within assigned project team to plan / manage projects for assigned projects. With support, capable of managing risk detection, prevention, and mitigation activities within assigned projects. Facilitates the planning with management and client(s) to define project requirements, scope, and objectives that align with the company's goals Partners with internal and external stakeholders to determine project budgets Reviews project proposals and plans to develop project objectives Develops a comprehensive project management workflow Ensures regular updates are communicated to internal and external stakeholders on project schedules, change proposals, and other activities Monitors resources to improve project efficiency and maximize productivity Develops and maintains the project performance database to track progress and milestones Monitors project progress to ensure project is on track to meet codes, standards, timelines, budget requirements, etc. Analyzes project(s) progress and notifies stakeholders to adjust timelines, as needed to achieve optimal results Identifies potential project risks and provides constructive suggestions when escalating to management or required stakeholders Adjusts priorities due to demands and unanticipated events Develops and implements risk strategies to minimize impact and deviations from estimated budget and timelines Builds and maintains positive relationships with external stakeholders by providing prompt responses, updates, and support Coordinates the procurement of materials, supplies, and vendors necessary for project completion Organize and delegate tasks to project team members to ensure successful completion Assists with conducting any required training for project members Delivers effective, engaging, and informative presentations, as needed Provides guidance and coaching to project member Other duties, as assigned Who You Are You are capable of planning and leading assigned projects. You have the ability to effectively communicate and establish partnerships with project team members. You establish and leverage site subject matter experts to assure project delivery and communication successes. You can provide problem solving and advice within the project team to tackle routine project challenges. You have strong time management skills. You have the ability to adapt in a fast-paced environment by pivoting and adjusting plans accordingly. You have a team based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others.
Basic Requirements Bachelor's degree with 8 or more years' experience in PMO relevant work OR High School Diploma with 12 or more years' experience in PMO relevant work Mature project management, project management software and continuous improvement competencies Preferred Requirements Bachelor's degree in project management Previous biopharmaceuticals experience PMP Certification Lean Certification; Yellow, Green, Black Belt Certification; or other continuous certification or experience PHYSICAL REQUIREMENTS PHYSICAL DEMANDS Ability to discern audible cues WORKING ENVIRONMENT PHYSICAL DEMANDS Ability to sit for prolonged periods of time. Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 lbs. ENVIRONMENTAL CONDITIONS Will work in heights greater than 4 feet 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 . 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.
