Quick Overview
Job Description
The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities.
The Lead, Manufacturing Operations will primarily be responsible for 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, Thurs-Sat & Alternating Wednesdays
Schedule is subject to change based on needs.
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