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Overview
The Associate Director, Data Integration and Reporting leads and drives the manufacturing data architecture design for the global implementation at FUJIFILM Biotechnologies. This role also leads the system life cycle activities for the global implementation of manufacturing data systems, such as historians, and reporting and integration platforms. This role continues to develop as the organization evolves.
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.
What Youll Do
Develops and implements strategies aligned with the companys goals to optimize processes, improve efficiency, and reduce costs
Serves as the system owner for the global historian platform
Drives the technical design and implementation of data integration, globally
Defines and supports the governance of global manufacturing data platforms
Ensures effective implementation and adoption of historians, reporting applications, and other data systems across all sites
Identifies and implements changes to support production and improve quality, as needed
Trains and shares information of data platforms to the Automation teams and required stakeholders
Leads global colleagues to effectively implement processes, procedures, and work standards
Manages relationships with external vendors to properly execute Automation tasks, as needed
Ensures standards, systems, and processes comply with regulatory requirements (e.g., Good Manufacturing Practices (GMP))
Directs the technical activities related to reporting applications and data systems to align with the companys objectives
Identifies, develops, and revises standard operating procedures (SOPs), as needed
Identifies opportunities for improvement and collaborates with stakeholders to implement continuous improvement initiatives
Provides guidance and training to Automation teams and other stakeholders globally, as needed
Encourages a culture of continuous learning and development while providing real-time feedback and coaching
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Evaluates team performance, addresses gaps, employee questions and concerns, and partners with HR as needed for resolution, as needed
Performs other duties, as assigned
Knowledge and Skills
Ability to adapt communication styles to differing audiences and advise on difficult matters
Knowledge of biopharmaceutical production within Fill Finish, Utility, Pens/devices, and Automation/IT
Strong strategic thinking skills
Ability to coach, lead, and train individual contributors
Ability to effectively present complex information to others
Effective communication, both written and oral
Basic Requirement
Bachelors degree in Chemical, Electrical, Mechanical Engineering or other relevant field with 11+ years of experience in a regulated industry
8+ years of people management / leadership experience
Prior experience working in a CGMP facility
ISA-S88
ISA-S95
Preferred Requirements
Masters degree in a technical field of study relevant to Automation, Instrumentation & Controls, or Business Management with 9+ years of related experience in a regulated industry
Experience with Lean Six Sigma or other continuous improvement methodologies
ISA-S18.2
Seniority level Seniority level Director
Employment type Employment type Full-time
Job function Industries Pharmaceutical Manufacturing
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Inferred from the description for this job Medical insurance
Vision insurance
401(k)
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