Overview

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.

External US

About This Role

The Master Data Coordinator 2 manages the master data processes to support both drug substance and drug product manufacturing. This role is responsible for the creation and management of raw material, Bill of Materials (BOM), and recipe master data in the Systems, Applications, and Products (SAP) S4/ Hana Enterprise Resource Planning (ERP) and the Manufacturing Execution System (MES) system. The Master Data Coordinator 2 supports the site, working closely with other departments (e.g., Manufacturing, Quality, Process Sciences, Finance, Warehouse) and collaborating with a global FDB network for master data. The Master Data Coordinator 2 creates, maintains, and phases out master data in SAP throughout the life cycle of a product to support the key processes. This role collaborates with internal customers for effective and efficient results for aggressive timelines. The Master Data Coordinator is actively leading and/or participating in many cross functional assignments, as well as working independently to delivery master data needs for customers.

What You’ll Do

• Executes SAP and MES system changes for materials and production processes

• Creates and maintains Master data setup for Raw materials, Drug Substance and Drug Product

• Works cross functionally to acquire data

• Participates in projects/initiatives for SAP support

• Ensures data integrity and compliance for SAP and MES data

• Manages, analyzes, revises, and resolves issues for master data

• Manages and owns actions for change controls to implement or revise master data for Raw material, Drug Substance and Drug Product

• Creates, maintains, and phases out master data in SAP throughout the life cycle of a product to support the key processes (e.g., new product launches, compliant product changes, introduction of new manufacturing resources and accurate phase out of products)

• Runs queries in SAP to periodically review master data inconsistencies and drive resolution with stakeholders

• Creates and leads change request for new material enrollment and material changes in through the change management system

• Performs data queries, analysis, and visualization to support the business and focus on data quality

• Performs mass updates and completes data cleansing as needed

• Supports training and communication of functional master data governance including standards, definitions, processes, policies and tools to team members and stakeholders

• Assists with continuous improvement of data management, resolves master data issues, links master data between systems and ensures quality, compliance, and consistency of master data

• Promotes and supports the use of accurate and reliable information across the company to enable optimal decision making

• Works closely with various business teams to resolve master data issues as needed while ensuring compliance and consistency of master data across business systems

• Creates and manages Change Management Record (CMR) within the Supply Chain acting as a change coordinator

Basic Requirements

• Bachelor’s degree in Supply Chain, Engineering, Information Science, Data Management, Computer Science, or related field with 2+ years of related experience

Preferred Requirements

• Ability to develop and maintain business and technical documentation, preferably with cGMP background

• SAP S4/HANA or other SAP ERP system experience

• Syncade, PAS X or other MES system experience

• GMP regulation experience

• Experience with data management

• Advanced Excel skills

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 FDBNPNC@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.

Job Locations US-NC-Holly Springs

Posted Date 1 week ago (10/15/2024 12:49 PM)

Requisition ID 2024-28166

Category Supply Chain

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies