Project Leader, Biopharma Operations (cGMP Readiness) – RTP Area

Our client, a highly respected and rapidly expanding consulting firm that supports the pharma manufacturing industry, has an immediate need for an exceedingly sharp and knowledgeable Project Leader to oversee the Operational Readiness aspects of its state-of-the-art biomanufacturing facility.

This firm has been working with an RTP area biomanufacturer that is building out a $2 billion operation.  The company will manufacture monoclonal antibody drug substance and drug product, and the build-out has been an enormous, multi-year undertaking.

Monitoring the ongoing progress and ensuring operational readiness and excellence will be an essential component of its success.  This Project Leader will drive this effort.

Role will involve leading the identification, prevention, and remediation of risks to cGMP operations readiness for the greenfield, large-scale facility.  The Project Leader will oversee the work of both internal employees and external consultants and ensure that

• all operations readiness efforts are progressing as planned
• all stakeholders are aware of and handling their responsibilities
• risks to CGMP readiness are identified and remedied swiftly and effectively
• timelines and budgets are maintained and, if not, proper adjustments are made and communicated

Specific duties will include:

• Develop project management plans for the risk management portion of the operations readiness project and manage delivery.
• Develop communication plans regarding risk management for operations readiness.
• Drive prospective weekly gemba and deep dive for key milestone objectives within the operations readiness plans.
• Drive response and action plans to significant issues impacting the delivery of on-time high-quality cGMP operations readiness for the facility.

This is a critical role and finding the right candidate is a top priority at this time.

Targeted candidate will offer a related degree (Engineering or similar preferred) and 5+ years of experience in manufacturing operations, including significant experience in the biopharma space. Some facility start-up/build-out experience will be important. Lean/Agile training also desirable.

Other priorities include:

• Deep technical expertise including keen understanding of biomanufacturing equipment and processes; Strong preference for those coming from cell culture, purification, and/or fill-finish facility operations.
• Expertise in driving cGMP operations readiness programs for greenfield facilities
• Experience implementing processes for risk identification, prevention, and remediation
• Familiarity with support areas such as laboratories, warehouse, maintenance, utilities, etc.
• Outstanding project management skills including the demonstrated ability to lead others to shared success

Finally, we seek a natural leader with the demonstrated ability to thrive in a fast-moving, high-impact role; someone who is proactive, resourceful, adaptable, mission-driven, and who demonstrates superb problem-solving, keen operational savvy, polished communication and unifying team leadership skills.

This is an immediate need and a Direct Hire opportunity.  Please forward Word resume for prompt consideration.