Project Manager, Manufacturing Operations (Biomanufacturing)
Job Description
Seeking a Project Manager with experience in driving complex, full-scale Upstream (Cell Culture) and Downstream (Purification) manufacturing projects to completion. This role is built for a strategic operator who excels at bridging the gap between current state and future-ready operations, navigating fast-paced matrix environments to deliver seamless project execution.
100% onsite in Durham/RTP, NC
Contract position, starting at 6 months
Core Responsibilities:
- Lead Cross-Functional Teams: Drive project execution across QA, Automation, Manufacturing, and Manufacturing Technical Operations.
- Operational Readiness: Map "current vs. future state" for manufacturing changes and execute actionable deliverables.
- Autonomous Execution: Manage assigned workstreams independently while providing clear, high-level status roll-ups to leadership.
- Strategic Communication: Lead discussions to define action plans, mitigate risks, and ensure on-time delivery.
Qualifications and Must Haves:
- Industry Expertise: Proven PM experience in Large-Scale Drug Substance manufacturing.
- Hands-on experience: with MES/Electronic Batch Record design or implementation.
- Direct operations: QA with Drug Substance and/or Drug Product Manufacturing.
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