Sr. Director, Strategic Projects

Overview

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

The Senior Director, Strategic Projects will lead front-end engineering design (FEED) and conceptual design phases for a large-scale monoclonal antibody drug substance facility. Reporting to the Chief Technology & Transformation Officer, this role will serve as the technical lead and primary owner of the engineering contract, driving strategic decisions from site selection through facility build and operational readiness.

• 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 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…