CBM

Full Time EE - Onsite

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

Responsible for the qualification, data analysis, data accuracy and change control of master data. The Data Steward creates and/or modifies data definitions and data, including, but not limited to all objects, views and fields within or associated with ERP. Working independently, the incumbent utilizes operations and supply chain knowledge, business process knowledge and SOPs to correctly maintain master data. Collaborate with other subject matter experts across multiple functions as well as communicate and interact with other Operational and Information Stewards to resolve issues regarding master data. Responsible for qualification and classification of data ensuring that all information is accurate and complete, performing ongoing maintenance of records and communications in accordance with company policies. In addition, offer recommendations to enhance workflow and increase efficiency.

Responsibilities

• Design and develop data strategies for multiple department business processes.
• Establish and maintain data governance structure and rules.
• Define data details in alignment with supply chain, quality and financial needs.
• In conjunction with business owners, assist in the development of data definitions and business rules.
• Responsible for the qualification, data analysis, data accuracy and change control of Master Data.
• Create and/or modify data, including but not limited to all objects, views and fields within the function.
• Maintain accurate, up-to-date master data for assigned business processes, ensure timely updates and eliminate duplicate/obsolete data.
• Measure, monitor and report on data quality on ongoing basis.
• Resolve data usage issues in timely manner.
• Communicate and interact with other Operational and Information Stewards to resolve issues regarding master data.
• Offer, evaluate and implement recommendations to enhance workflow and increase efficiency.
• Review Create and Change forms for accuracy and completeness, ensure necessary approvals are obtained, perform searches to determine whether request is duplicate, ensure request approval, interpret requests to determine appropriate course of action obtaining additional clarification if necessary.

Qualifications

• Bachelor’s Degree in a related technical or business concentration (Supply Chain, PM, Logistics Planning, Engineering, Procurement, Accounting, Finance, Business Planning or equivalent) required.
• A minimum of two (2) years relevant work experience.
• Knowledge of ERP required, knowledge of SAP desired.
• Understand biological or pharmaceutical manufacturing processes
• Experience working within a regulated industry
• Broad understanding and knowledge of applicable business processes.
• Solid oral and written communication and interpersonal skills.
• Teamwork and collaborative focus.
• Ability to function in a high activity environment with tight deadlines.
• Attention to details and accuracy.