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. ...