Opportunity Description
Responsibilities:
- Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required.
- Act as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines.
- Review and/or author technical protocols, reports or memos.
- Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
- This includes overseeing data collection and analysis, ensuring ongoing process performance and control, partnering with CMOs to identify and mitigate risks, and driving continuous improvements to strengthen product robustness. ...
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