Head Of Downstream Manufacturing Science

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 solutionsto 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.
Process Science is a department that provides scientific leadership throughout the product lifecycle to support clinical and commercial Drug Substance manufacturing, Drug Product, as well as Finished Goods. The Head of Downstream Manufacturing Science will play a key role in designing the strategy, building and developing a team of scientists/engineers, and optimizing our manufacturing process for drug substance production. With a focus on innovation, you will drive continuous improvement with downstream projects and technology. You will be a valued and core member of our process science team and represent your function at client meetings. This position provides a unique and exciting opportunity to use your extensive knowledge in downstream development to shape the future of the manufacturing science team in this $2B large scale manufacturing site. The department continuously strives to identify opportunities to improve systems and practices and provides direction to the manufacturing group as well as technical development teams.
External US
Responsibilities :

• Develop and oversee a robust technical transfer process supporting at-scale transfer of manufacturing processes between manufacturing partners and locations. Author CMC sections of regulatory filings and support the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries.
• Assess, communicate, and mitigate key manufacturing process/ technology risks. Enable the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries.
• Perform tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing, and ensure manufacturability of the process. This includes acceptable process characterization/validation, risk assessments and mitigation and robust supporting data for the proposed changes.
• Create and implement the strategy for Downstream Manufacturing Science in close collaboration with our network
• Explore, assess, and recommend new equipment/platforms which improves manufacturing processes from a cost, efficiency, quality, and compliance perspective.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment/process issues.
• Oversee Downstream Process Science lab operations, process equipment and instrument care, maintenance, troubleshooting and data interpretation
• Hire, retain, train, lead and develop a team of scientists/ engineers and manage departmental budget, systems, processes, and team schedules
• Charter and execute continuous improvement projects, in partnership with manufacturing where applicable, to improve manufacturability, reliability, yield and cost.
• Partner with clients to define requirements and understand functional/specifications process requirements.
• Provide leadership and direction to the manufacturing site to define the process requirements for execution of clients manufacturing processes.
• Function as senior leader in support of supplier technical evaluations, risk assessments, and raw material evaluation and qualification.
• Continuously seek to optimize the manufacturing processes to ensure effective use of capacity and minimize costs.
• Function as senior technical leader and contact for client projects, communicating project status and technical explanations
• Manage a team to lead, develop and implement scientifically sound and fit for purpose policies and procedures based on current regulations, industry standards and industry practices for drug substance manufacturing, process and technology transfer, and process validation.
• Partner with Client, Process Development, Quality, Manufacturing and Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of technology transfers as needed.
• Provide team support for critical manufacturing investigations and technical oversight of deviations, change controls and CAPAs.
• Establish systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data.
• Play a key role in business development and defining the future large-scale operations model
• Resolve technical problems through scientific understanding and application of innovative solutions
• Responsible for leading all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification, and continued process verification, validation master plans, risk assessments, protocols and reports.

Requirements:

• Flexible, organized and solution-oriented mindset. Able to travel, domestic and international, 10-20%highly interactive environment.
• Prior drug substance development and manufacturing experience, including process validation, process transfer, commercialization, and manufacturing support and troubleshooting of downstream operations.
• Strong attention to detail, highly organized and the ability to multitask in a fast-paced, Experience communicating and collaborating cross-functionally; global collaboration experience preferred
• Minimum 10 years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and/or GMP manufacturing.
• Excellent communication and presentation skills
• Strong knowledge of US and international regulatory standards and ICH guidelines.
• Bachelor's or Master's degree in a scientific or engineering field. MS or PhD is strongly preferred.
• Demonstrated ability to hire and develop top technical talent and to build a high performing team, as well as leadership experience leading teams, projects, programs or directing the allocation of resources.

FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
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, email [email protected].
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.