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Technical Specialist Raw Materials
Remote, CA US
Posted: 06/05/2025
2025-06-05
2025-08-14
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
- 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)