Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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.

About This Role

The Associate Director, Drug Product and Finished Goods (DPFG) MSAT is the process owner, focusing on drug product and finished goods manufacturing at FDBN. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase, leads projects and owns the technical transfer set up and initiation for DPFG. Works closely with the commissioning, qualification and validation organization to ensure all equipment and processes are established and aligned, leads projects to create new processes and expands the capabilities and functionalities into operations. This role supports the Global team providing subject matter expertise level inputs for drug product and finished goods group and ensures the business processes are in place.

Major Accountabilities:

• Builds the DPFG MSAT team in alignment with current directives
• Hires, retains, trains, leads and develops a team of DPFG MSAT engineers and technical transfer associates
• Manages 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 product manufacturing, process and technology transfer, and process validation

• Leads the Drug Product and Finished Goods MSAT team in developing and maintaining internal data-focused webapps to support different stakeholders
• Provides leadership and direction to the manufacturing site to refine the process requirements for execution
• Partners with users (internal and clients) to define functional specifications and process requirements from a specifically process
• Partners with users (internal and clients) for data used to support continuous manufacturing and validation, continuous improvement and regulatory commitments
• Continuously seeks to optimize the manufacturing processes to ensure effective use of capacity and minimize costs
• Partners with Client, Program Design, Quality, Manufacturing and Engineering on platform development, technology innovation, scale-up, and manufacturability as part of technology transfers, as needed
• Ensures successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment/process issues
• Explores, assesses, and recommends new equipment/platforms which improves manufacturing processes from a cost, efficiency, quality, and compliance perspective
• Performs tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing ensuring manufacturability of the process. This includes acceptable process characterization/validation, risk assessments and mitigation and robust supporting data for the proposed changes. Is responsible for leading all aspects of process validation including: ancillary process validation (both at-scale and small-scale studies as applicable), process performance qualification, and continued process verification, validation master plans, risk assessments, protocols and reports
• Develops and oversees a robust technical transfer process supporting at-scale transfer of manufacturing processes between manufacturing partners and locations
• Authors or provides guidance to CMC sections of regulatory filings
• Supports the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries
• Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data
• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls and CAPA's
• Resolves technical problems through scientific understanding and application of innovative solutions
• Provides team support for investigations, root cause analysis, and optimization with data support and analysis
• Functions as senior technical leader and contact for process data and statistics
• Leads team in curating critical knowledge and developing best practices in DPFG manufacturing
• Serves as a key stakeholder, providing expertise inputs for business development and defining the future large-scale operations model for DPFG
• Coaches and mentors direct reports and team members to foster professional development and growth
• Enforces and ensures team adheres to company policies and procedures
• Participates in the recruitment process to attract talent
• Collaborates with other departments (e.g., HR, Talent Acquisition) and provides input to develop retention strategies
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in Life Sciences, Engineering or related field with 10 years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and/or GMP manufacturing
• Prior Drug Product and Finished Goods development and manufacturing experience, including process validation, process transfer, commercialization, and manufacturing support and troubleshooting
• Leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Requirements:

• Master’s degree in a scientific or engineering field
• Previous drug product, isolator start-up experience
• Experience communicating and collaborating cross-functionally;global collaboration experience

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, please email FDBN_PNC@fujifilm.com.

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.

PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes