Specialist Manufacturing

Fully onsite ATO
Please note working hours below (24/7 operations begins April 2027)
****** Supplier Call on Monday, 09/14 at 4:05 PM Eastern Time***. Please review the role details and come prepared with questions. Teams details below
Microsoft Teams meeting
Join: https://teams.microsoft.com/meet/***70499?p=Sv73Nk82tbLyvnC1DI
Meeting ID: ***70 499
Passcode: 4dZ65478
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- Serve as an aseptic processing technical resource supporting 24/7 drug product manufacturing. The role will begin with M-F 8-5pm, but transition to Wed-Sun 8-5pm once 24/7 operations commences in 2027.
- Support continuous improvement initiatives that strengthen aseptic compliance, process robustness, and operational efficiency.
- Revise controlled documents, including SOPs, work instructions, and related records, to support process changes and improvements.
- Own aseptic related deviations.
Support the 24/7 Ways of Working Lead to evaluate 1+ year of aseptic call log data from the floor and identify recurring trends, root causes, and improvement opportunities.
- Develop clear metrics, summaries, and actionable outputs that convert operational data into decisions, priorities, and follow-up actions.
- Establish and maintain a cyclic process for gathering information, addressing challenges, implementing improvements, and assessing effectiveness.