Quick Overview
Job Description
The Manufacturing Supervisor is responsible for leading GMP manufacturing operations supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance manufacturing activities. This role provides direct supervision of manufacturing personnel, ensures compliance with current Good Manufacturing Practices (cGMP), and drives safe, efficient, and high-quality execution of manufacturing campaigns.
The supervisor serves as a key operational leader, coordinating production activities, managing shift resources, supporting technology transfer and process validation activities, and partnering with Quality, Process Sciences, Supply Chain, Facilities, and MSAT teams to achieve production objectives. This role will be dedicated to the manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.
Example Plan Shifts/Training Schedule:
- First 2 weeks: 8 hour shifts, M-F
- Next 1-2 months: 10 hour shifts, Mon-Thurs
- After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays
Schedule is subject to change based on needs.
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