Sr. Director, Strategic Projects jobs in United States
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Avid Bioservices · 1 day ago

Sr. Director, Strategic Projects

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 and conceptual design phases for a large-scale monoclonal antibody drug substance facility, serving as the technical lead and primary owner of the engineering contract.

BiotechnologyHealth CareMedical
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H1B Sponsor Likelynote

Responsibilities

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
Evaluate potential locations for facility build, considering demographics, infrastructure, and workforce availability
Assess regional utilities, logistics, and regulatory requirements to support long-term operations
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
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
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
Track cumulative project expenditures against the approved budget, highlighting variances by major cost categories (e.g., engineering, construction, equipment, contingency)
Present updated projections for total project cost at completion, including explanations for any changes since the last report
Monitor monthly and cumulative cash flow versus plan, identifying timing mismatches or risks to liquidity
Summarize all approved and pending change orders, including financial impact and root cause (scope change, unforeseen conditions, etc.)
Highlight top financial risks and opportunities, with quantified potential impacts and mitigation status
Report on contingency usage, remaining balance, and justification for any significant draws
Track realized and projected savings from value engineering or cost optimization initiatives
List major contracts awarded to date, committed spend, and outstanding procurement actions
Identify any schedule delays or accelerations that have a direct effect on project costs (e.g., extended overhead, acceleration premiums)
Provide a visual dashboard with key financial KPIs, trend lines, and RAG (Red/Amber/Green) status indicators for rapid executive review
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

Qualification

GMP experienceCapital project leadershipMonoclonal antibody expertiseFEEDConceptual designEPCM project deliveryLeadership experienceStrategic planningBudgetingSchedulingRisk managementStakeholder management

Required

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

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

Benefits

Health, dental, and vision insurance
401(k) matching
Paid time off

Company

Avid Bioservices

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Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.

H1B Sponsorship

Avid Bioservices has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (5)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$285M
2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M

Leadership Team

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Kenneth Bilenberg
President & Chief Executive Officer
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Richard McAvoy
Chief Business Officer
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Company data provided by crunchbase