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Posted: 06/05/2025 Employment Type: Contract Job Category: Operations and Development Job Number: 4486

Job Description

Responsibilities:

Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). Interface cross-functionally (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers.
Draft specifications based on raw material attributes, where they are used in the process and how they should be controlled.
Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner

Basic Qualifications:

Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.
Project management experience
Experience in GMP controlled documents management
Knowledge of ERP Systems (SAP)

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