Head of Drug Substance Manufacturing Operations- Upstream

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.

As Head of Drug Substance Manufacturing (Upstream), you will play a critical role in the design and execution of DSM Operations strategy for the Holly Springs site.  You will ensure safe, compliant, and successful execution of the Drug Substance Manufacturing team.  You will lead leaders and work cross-functionally to ensure alignment with our partner in Denmark.

This position provides a unique opportunity to join a project on the ground floor and truly have an impact on the success of our site.  You will work in partnership with top-tier biopharmaceutical companies to manufacture cutting-edge, life-changing medications for the patients who need them.

External US

Responsibilities:

• Develop and implement DSM operational strategy for Upstream Manufacturing
• Accountable for operations from Media prep to cell culture seed train and the production bioreactor
• Build an efficient, diverse, and solution-driven DSM operations team
• Foster an environment focused on continuous improvement of manufacturing processes and systems
• Determine and evaluate DSM escalation flow
• Manage quality systems and mitigate potential risks regarding quality, safety and reliability
• Manage department budget for the manufacturing function including planning and management of capital expansion projects
• Collaborate and influence cross-functional teams and ensure priority alignment
• Ensure that manufacturing processes are cGMP compliant and meet relevant safety, environmental, labor and industrial health regulations
• Interface with clients and stakeholders, supporting commercial development and program management with proposal and scope of work development and review
• Participate in client presentations and interact with clients as the liaison to manufacturing
• Develop manufacturing schedules along with personnel and equipment requirements

Requirements:

• BA/BS Degree in scientific field is required; MA/MS is preferred
• 10+ years' experience in a cGMP pharmaceutical manufacturing environment
• 3+ years' leadership experience with a focus on empowering and developing teams
• Experience collaborating with cross-functional teams
• Excellent communication and presentation skills; comfortable presenting to teams, shifts, and clients
• Knowledge of cGMP, FDA and OSHA regulations
• Support a 24/7 manufacturing operation
• Attention to detail and an agile, solution-based mindset