Senior 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

The Senior Manufacturing Project Lead will act a manufacturing operations representative supporting the design and construction through to routine production operations. This individual will ultimately be part of the campaign life cycle team, supporting change over, column packing, and tech transfer activities. During the project phase this individual will support multiple operational readiness projects.

During the project phase:

Provide operational expertise required to ensure the facility is delivered on schedule, on budget, and in a state suitable to meet operational needs for the manufacturing organization.

Approach problems with an open mindset facilitating transfer of processes from our existing facility, while leveraging your experience.

Write, review, provide input, and/or approve Functional Specifications, procedures, and other operational documents.

Will be a key contributor and driver in preparation for operational readiness related to bulk drug substance manufacturing. Possible assignments include leading projects related to:

Procedure review and/or creation.

Support onboarding of Manufacturing staff.

Development or Transfer of Manufacturing business processes.

New Item creation.

Single-Use assembly transfer or design.

Participate in equipment vendor FATs, SATs, and on-site commissioning.

Work with cross-functional groups to organize equipment startup and transfer into GMP manufacturing.

Lead project change controls when necessary to ensure proper operation of equipment.

Ability to lead teams, facilitate workshops, coordinate effective communication and cooperation, and drive results to ensure operational readiness resulting in successful start-up and completion of the facility while moving into GMP operations.

Once operational:

Own more complex projects and assignments, which may be supported by additional team members

Provide guidance to more junior team members

Generation of changeover documentation and project management of changeover activities.

Generation of column packing documentation and management of column packing activities.

Perform or manage general training associated with the tech transfer of new products.

Support materials management within manufacturing.

Job Requirements

Bachelor’s degree in Engineering, Biology, Chemistry, Life-Sciences etc. and 8+ years’ experience from similar role in large pharma/biotech operations or projects.

Associate degree in Life-Sciences and 10+ years’ experience from similar role in large pharma/biotech operations or projects

HS diploma 12+ years’ experience from similar role in large pharma/biotech operations or projects.

Experience in in manufacturing of biological products, familiar with GMP/GLP requirements.

Good communication skills and fluency in English

Agility and flexibility as required in a project role where tasks and responsibilities are not limited by the group in which you reside or your documented job title or responsibilities.

Must have excellent work ethics, personal responsibility, initiative and teamwork.

Must have excellent attention to detail and quality requiring little rework.

Flexible to work productively independently or in a team-oriented environment under limited supervision.

Working Conditions & Physical Requirements

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.

Have a normal range of vision.

Required to lift up to 50 pounds on occasion.

Climb ladders and stairs of various heights.

Be exposed to wet or humid conditions.

Be exposed to noisy environments.

Attendance is mandatory.

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 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.