Director, Manufacturing Support

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 Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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

Bachelors Degree with an emphasis in life science engineering or related field with 12 years experience in biotech/pharma ORtransferrable military experience
6 years leading others or leading in a matrix environment

Preferred Requirements

Masters 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 viaemail 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 committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().