Director, Process Analytics

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

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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 Director, Process Analytics sets the strategic direction and execution of Manufacturing Intelligence / Process Analytics solutions across FUJIFILM Diosynth Biotechnologies Holly Springs (FDBN) end-to-end manufacturing value chain (Drug Substance, Drug Product, and Finished Goods).

This role establishes and maintains informatics systems for process analytics purposes, leads projects to create new process analytics systems, and expands the capabilities and functionalities.

This role supports Process Science, and ensures the systems are effectively implemented to support the business processes in place for the site.

Additionally, this role creates multivariate models and provides training in the use of process analytics systems that are currently in place.

Major Accountabilities

• Builds and develops the Process Analytics team to deploy digital solutions for real-time process monitoring and multivariate statistical process control.
• Establishes the vision and direction for the Process Analytics team and individual to drive innovation and growth.
• Provides strategic leadership to the architecture, design, and deployment of the site's process data platforms, and oversees the integration of machine learning models, data science applications, and custom applications and dashboards to enhance business capabilities and innovation.
• Leads the Process Analytics team in developing and maintaining internal data-focused webapps to support different stakeholders.
• Seeks to continuously optimize the data management of manufacturing processes while focusing on digital solutions.
• Partners with users (internal and clients) to define functional specifications and process requirements from a process data perspective, specifically process data transmittance (sensor, control, and operation data).
• Partners with users (internal and clients) for data used to support continuous manufacturing and validation, continuous improvement and regulatory commitments.
• Leads innovations and systems improvement initiatives in the Process Analytics space (e.g., new in-line and on-line Process Analytical Technologies (PAT) solutions for biopharmaceutical processes with a strong focus on production process monitoring and control).
• Trains relevant stakeholders on PAT tools and respective analytical approaches (e.g., multivariate models and other statistical process methods).
• Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data.
• Oversees and provides support for investigations, root cause analysis, and optimization with data support and analysis.
• Functions as senior technical data leader and contact for process data, statistics, modeling, and PAT activities (e.g., automation interface between PAT analyzers and sensors and data systems).
• Drives the team’s efforts in curating critical knowledge and developing best practices in Process Analytics domain.
• Serves as a key stakeholder in business development and defining the future large-scale operations model, including site's digital roadmap of GxP process data.
• Designs the development of applications and methods with model for process characterization and scale-up / out (e.g., transition analysis to monitor column integrity, e-chromatogram review).
• Serves as a mentor and oversees development of employees to ensure the team is positioned for growth.
• Partners with HR, Talent Acquisition, and other stakeholders to attract talent and develop retention strategies.
• Evaluates the team’s performance, implements measures to improve productivity and engagement, and develops high-potential employees.
• Other duties, as assigned.

Knowledge, Skills and Abilities

• Strong knowledge of US and international regulatory standards and ICH guidelines especially with regards to data integrity.
• Knowledge of PAT methodologies, implementation, data science, SIMCA-Online, TIBCO Statistical, Visual Basic and Git version control.
• Strong attention to detail, highly organized, and solution-oriented mindset.
• Ability to multitask in a fast-paced, highly interactive environment.
• Ability to adapt communication style to differing audiences and advise others on difficult matters.
• Effective communication, both written and oral.
• Ability to effectively present complex information to others.
• Ability to provide feedback to others, including leaders.
• Advanced problem-solving skills.
• Demonstrated ability to hire and develop top technical talent to build and lead a high performing team, projects, programs while directing allocation of resources.
• Must be willing to travel domestic and international, up to 20%.

Minimum Requirements

• Bachelor’s degree in Engineering, Scientific or Mathematics field with 15+ years of relevant experience (e.g., Statistical Control of Manufacturing Processes or Development of Data Collection / Management Systems); or
• Master’s degree with 12+ years of relevant experience 5-7 years of previous management or supervisory experience.
• Prior experience with data mining, management and visualization, statistical process control, and manufacturing processes.
• Experience with different machine learning algorithms and command of data science ecosystem.

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment.
• Experience using IT systems to support data acquisition, management, and evaluation.
• Prior experience collaborating and interacting with a global team.
• Experience with multivariate data analysis.

Working Conditions & Physical Requirements

Will work in environment which may necessitate respiratory protection. May work in Mechanical / Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Will work in environment operating a motor vehicle or Powered Industrial Truck. Ability to discern audible cues. Ability to inspect or perform a task with 20 / 20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time. Ability to sit for prolonged periods of time.

Ability to conduct activities using repetitive motions that include wrists, hands and / or fingers. Ability to operate machinery and / or power tools.

Ability to conduct work that includes moving objects up to specified pounds. Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions.

Will work in warm / cold environments. Will work in outdoor elements such as precipitation and wind. Will work in small and / or enclosed spaces.

Will work in heights greater than 4 feet.

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 identity or any other protected class.

If an accommodation to the application process is needed, please email FDBN [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.

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