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 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.
About This Role
The Senior Business Continuity & Resiliency Specialist supports business recovery, crisis management, emergency management, contingency planning, and disaster-preparedness planning. The Senior Business Continuity & Resilience Specialist provides supports and expertise pre, during and post disruptions. This position also conducts, communicates, and maintains the FDBN business continuity lifecycle to include all associated procedures, policies, and SOPs. Additionally, this role carries out duties in a professional manner to include use of the Human Performance Tools, Safe Work Practices and Procedure Use & Adherence.
What You’ll Do
- Assists in the development of business continuity and disaster recovery plans
- Oversees testing, emergency response protocols, and recovery procedures
- Documents testing outcomes, gaps identified, and remediation needs
- Provides guidance for the selection of strategies for the restoration and overall continuation of the business within a Recovery Time Objective (RTO)
- Supports business recovery, crisis management, emergency management, contingency planning, and disaster-preparedness planning
- Serves as the subject matter expert (SME) and provides expertise during disruptions (e.g., natural disasters, technology failures, etc.)
- Maintains and communicates the business continuity lifecycle effectiveness
- Builds and maintains business relationships with audit and government regulators on business continuity issues
- Maintains records and reports the compliance of business continuity processes, readiness, events, and exercise results
- Develops, enhances, and disseminates information on continuity processes, standards, and initiatives
- Conducts risk assessments and business impact analyses to identify potential risks
- Creates and maintains resilient response plans
- Supports the development and delivery of training to ensure site-wide alignment and effective implementation of protocols and plans
- Develops and revises operational and tactical plans, procedures, training materials, and other written products
- Coordinates security requirements with other site organizations
- Facilitates cross-functional collaboration and coordinates with internal and external stakeholders to improve business continuity efforts and response capabilities
- Establishes effective communication channels to ensure timely information is shared pre, during, and post disruptions
- Other duties, as assigned
Knowledge and Skills
- Possess an in-depth knowledge of international BCM ISO standards and FDA cGMP requirements
- Effective communication, both written and oral
- Strong problem-solving and time management skills, and attention to detail
- Ability to identify critical issues promptly and address effectively
- Team-based attitude and ability to work within a global team environment and build relationships
- Ability to effectively present complex information to others
- Knowledge of security operations, safety regulations and procedures, including emergency response protocols
- Ability to adapt to changing environments and respond quickly to emergencies
- Ability to mentor, support, and provide feedback to others
- Ability to work outside regular business hours to support testing, training, and real life disruptions
Basic Requirements
- Bachelor’s degree in emergency management, homeland security, or related field with 8+ years of experience in business continuity management, emergency management, and regulatory compliance
- Prior experience leading a small team or projects
- Valid driver’s license
Preferred Requirements
- Experience working in a cGMP facility or with the FDA
- Prior experience leading a small team or projects
- Experience with computer software, such as Microsoft PowerPoint, Excel, Word, Teams, Adobe, etc.
- Certified Business Continuity Professional (CBCP)
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.
