Sr. Director, Strategic Projects

Avid Bioservices•Tustin, CA

2d•$220,000 - $290,000

About The Position

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. Your Role: 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.

Requirements

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

Nice To Haves

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

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.