Project Manager, Manufacturing Operations (Biomanufacturing)

Randstad Enterprise; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

A recruitment firm is seeking a Project Manager experienced in large-scale drug substance manufacturing. This contract position requires leading cross-functional teams, ensuring operational readiness, and delivering projects independently. The ideal candidate will have hands-on experience with MES/Electronic Batch Record systems and strong project management skills. Located in Durham, NC, this role focuses on navigating fast-paced environments to drive project success.

Qualifications

• Proven PM experience in large-scale drug substance manufacturing.
• Hands-on experience with MES/Electronic Batch Record design or implementation.
• Experience with QA in drug substance and/or drug product manufacturing.

Responsibilities

• Lead project execution across QA, Automation, Manufacturing, and Technical Operations.
• Map current vs. future state for manufacturing changes.
• Manage assigned workstreams and provide high-level status updates.
• Lead discussions to define action plans and ensure on-time delivery.

Skills

Project Management

Communication Skills

Cross-Functional Team Leadership

Risk Mitigation

Tools

MES/Electronic Batch Record

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.

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.