The Director, Manufacturing Support is responsible for leading the department and the associated activities to ensure compliant and reliable drug substance manufacturing. This role applies broad knowledge and expertise in the areas of biopharmaceutical manufacturing, manufacturing support, and
operational excellence. This position provides tactical and strategic direction to the Manufacturing Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

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.

What You’ll Do

• Leads all areas of Manufacturing Support (e.g., change controls, technology transfer, process performance qualification, investigations, campaign readiness, corrective action preventive action (CAPAs), production scheduling, training, changeover, production documentation, and manufacturing execution systems)
• Develops Manufacturing Support goals and strategy in alignment with the production schedule
• Drives Manufacturing Support key performance indicators (KPIs) to support quality, continuous improvement, while escalating and mitigating manufacturing issues
• Administers company policies that directly impact employees
• Oversees hiring, training and development for all Manufacturing Support staff
• Ownership and oversite of manufacturing systems and business processes, including manufacturing IT and automation systems as well as document driven business processes
• Interacts professionally with clients and partners to effectively communicate manufacturing support deliverables and commitments
• Leads discussions and responses during inspections, including area readiness prior to these inspections
• Drives and supports alignment and coordination between other FDB sites on manufacturing topics
• Prepares departmental budget, tracks spending and deliverables against budget and timelines
• Performs other duties, as assigned

Basic Requirements

• Bachelor’s Degree with an emphasis in life science, engineering, or related field with 12+ years’ experience in biotech/pharma OR transferrable military experience
• 6+ years leading others or leading in a matrix environment

 Preferred Requirements

• Master’s degree + 10 years’ experience in a similar role in a large pharma/biotech environment
• Manufacturing operations or Manufacturing Support experience

• Lean or Six Sigma

WORKING ENVIRONMENT

PHYSICAL DEMANDS 

• Ability to stand for prolonged periods of time 
• Ability to sit for prolonged periods of time
• Ability to conduct work that includes moving objects up to 10 pounds

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.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).