Associate Director, Drug Product Manufacturing - Fujifilm

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.

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

The Associate Director for DPM is responsible for executing GMP readiness and preparing for the operation of the new facility to support customer onboarding. The organization consists of operational teams for Filling, Formulation, wash and sterilization, as well as inspection and support. This role will additionally be responsible for establishing a culture in alignment with our Leadership principles and deliver according to our End to End (E2E) strategy and customer agreements. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours.

What You’ll Do

• During the project phase, you will be responsible for the creation, ownership and tracking of the execution for the Operational Readiness Plan; including, but not limited to developing Standard operating procedures(SOPs), project timelines, staffing plan and budgets for the Drug product manufacturing area

• Lead, manage and support the area managers, supervisors as well as associates as they focus on the personal team and process development

• Define and own the business processes for Drug Product functions; including Formulation, Aseptic filling and manual/ automated visual inspection

• Provide input and expertise on the subject of Drug Product manufacturing (DPM) for Risk assessment, such as: (FMEA), QRA and Operations

• Ability to share and development best practices and continuous improvement in Drug Product

• Provide input and support for robust deviation investigation, CAPA (corrective and preventive action), ownership and process monitoring

• Manage and own departmental budgeting and monitoring, as well as overall fiscal performance for your functional area

• Understand, develop and drive KPIs for the Drug product team

• Develop, own and maintain staffing plan

• Collaborate with other FDB locations and Clients

• Evaluate, assess and develop timelines and communicate to relevant stakeholders

• 0-25% travel required

• Other duties as assigned

Who You Are

You have demonstrated experience in team arrangement and problem solving. You have strong facilitation skills and proven leadership within cross-functional teams. You have a proven track record for implementation within established deadlines. You are able to interpret technical information and documentation used for operations and production activities. You have experience in management of diverse stakeholders with stronger interpersonal/influencing skills and the ability to communicate effectively. You have the practical demonstrable knowledge of cGMP and compliance regulations. You have direct proven experience within Drug Product Operations or 7 or more years.

Basic Requirements

• Bachelor’s Degree

• At least 7 Years of Drug Product Experience

• At least 10 Years of Pharmaceutical Experience

Preferred Requirements

• Bachelor’s Degree, STEM Specific

• At least 10 Years of direct, hands-on Drug Product experience

• Prior experience in client interface

• Previous experience leading and developing leaders (Managers/Supervisors)