Description

Key Responsibilities: 

Lead FEED and Conceptual Design Phases

• Oversee development of 2KL scale-out and 5KL scale-up facility build options.
• Direct engineering partners to deliver conceptual layouts, process flows, and facility sizing.
• Ensure integration of process equipment, warehousing, clean/dirty utilities, QC labs, and office space.

Site Selection and Feasibility

• Evaluate potential locations for facility build, considering demographics, infrastructure, and workforce availability.
• Assess regional utilities, logistics, and regulatory requirements to support long-term operations.

Budgeting and Scheduling

• Deliver comprehensive project budget and schedule to P20 accuracy at the conclusion of FEED.
• Provide cost and timeline risk assessments to inform executive decision-making.

Governance and Stakeholder Engagement

• Serve as technical lead for the user team, owning the engineering company contract.
• Prepare and present key inputs for board proposals, including design options and financial models.

Organizational Planning

• Define organizational structure and resource needs for subsequent phases: Basic Design, Detailed Design, Engineering, and Construction Management.
• Support onboarding of EPCM partners and ensure alignment with project objectives.

Key Financial Metrics & Reporting Practices

• Budget vs. Actual Spend: Track cumulative project expenditures against the approved budget, highlighting variances by major cost categories (e.g., engineering, construction, equipment, contingency).
• Forecast at Completion (FAC): Present updated projections for total project cost at completion, including explanations for any changes since the last report.
• Cash Flow Tracking: Monitor monthly and cumulative cash flow versus plan, identifying timing mismatches or risks to liquidity.
• Change Order Log: Summarize all approved and pending change orders, including financial impact and root cause (scope change, unforeseen conditions, etc.).
• Cost Risk Register: Highlight top financial risks and opportunities, with quantified potential impacts and mitigation status.
• Contingency Drawdown: Report on contingency usage, remaining balance, and justification for any significant draws.
• Value Engineering Savings: Track realized and projected savings from value engineering or cost optimization initiatives.
• Major Contract Commitments: List major contracts awarded to date, committed spend, and outstanding procurement actions.
• Schedule-Driven Cost Impacts: Identify any schedule delays or accelerations that have a direct effect on project costs (e.g., extended overhead, acceleration premiums).
• Executive Summary Dashboard: Provide a visual dashboard with key financial KPIs, trend lines, and RAG (Red/Amber/Green) status indicators for rapid executive review.

Execution Leadership

• Transition from FEED to full project execution, leading build, commissioning, qualification, and validation (CQV) activities.
• Drive readiness for operational handover, ensuring compliance with GMP and regulatory standards.

Minimum Qualifications:

• Minimum of 12+ years of professional experience, including at least:
• 10+ years working in GMP-regulated environments
• 8+ years supporting or leading capital projects
• Bachelor’s degree in Engineering or a closely related field required
• 8+ years of leadership experience, including direct reports and/or professional contracted staff
• Demonstrated experience leading teams, with team size scaling based on project demand from approximately 2–3 team members up to 20 during peak project periods

Preferred Qualifications:

• Advanced degree preferred
• Proven experience supporting large-scale biopharmaceutical facility design and construction projects
• Deep expertise in monoclonal antibody drug substance manufacturing processes
• Strong working knowledge of FEED, conceptual design, and EPCM project delivery models
• Demonstrated ability to manage complex stakeholder relationships and lead cross-functional teams
• Exceptional skills in strategic planning, budgeting, scheduling, and risk management across large capital programs

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.