Operational Readiness Manager - Project Farma

Responsibilities

Serve as a trusted advisor to senior stakeholders, including Vice Presidents of Engineering and Operations, and Site and Quality Leaders.

Provide strategic leadership in developing and executing Operational Readiness Plans and Assessments, either in-house or as a consultant.

Lead large, complex capital facility projects with budgets exceeding $5M.

Demonstrate deep understanding of Operational Readiness stage-gate processes and clearly articulate these to stakeholders and clients.

Lead cross-functional Operational Readiness teams in both internal and consulting environments.

Possess end-to-end knowledge of capital project execution, from design through start-up, including effective handoffs between Capital Project Execution and End User Operational Readiness teams.

Lead cross-functional teams (Engineering, Operations, Quality, Supply Chain) from Operational Qualification (OQ) completion through initiation of PPQ batches.

Maintain strong knowledge of biopharmaceutical manufacturing facilities, including Drug Substance and Drug Product/Packaging operations.

Lead and manage all start-up readiness elements, including consumables and raw material planning, engineering asset induction, and CMMS configuration and implementation.

Leadership Skills

• Demonstrated Leadership skills running large (10-20 people) cross-functional teams in a start-up environment, either in-house or as a consultant.
• Ability to prioritize and set key milestone targets for the Operational Readiness Team, then drive to achieve those milestones.
• Ability to work in a fast paced team environment with rapidly changing scope and priorities.
• Excellent Planning and Organizational skills to manage large complex facility start-ups

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
• Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required

• Bachelor’s Degree (and/or Masters) in Life Sciences, Engineering, Regulatory or related discipline OR a combination of equivalent experience in quality assurance, cGMP facility start-up, regulatory assurance, relevant military and/or professional services.
• 8-14+ years directly relevant experience required
• Minimum 7+ years’ Bio-Pharmaceutical industry experience
• Capital Projects experience in a GMP pharmaceutical environment
• Operational experience moving from capital execution to true facility start-up
• Willingness to travel as required to support project and business needs.