Senior Project Manager

Fraser Dove International; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

Fraser Dove International seeks a Regional Project Head, US to lead the Drug Substance capital project portfolio across its US manufacturing network. The role requires delivering complex greenfield and brownfield facilities on time and within budget, with strong contractor management and CQV alignment.

You will drive fast-track schedules, manage EPC/EPCM contractors and ensure compliance with cGMP and FDA expectations, while mentoring project teams to achieve global engineering standards and

Qualifications

• 10+ years of capital project leadership in pharma/biotech/CDMO industries.
• Experience delivering greenfield and brownfield Drug Substance projects.
• Knowledge of cGMP, FDA expectations, and US building codes.
• Strong matrix leadership and contractor management experience.
• Experience with CQV and regulatory inspections (FDA PAIs).

Responsibilities

• Lead greenfield and brownfield Drug Substance capital projects across US sites.
• Drive fast-track schedules, project controls, budget tracking and stage-gate governance.
• Manage EPC/EPCM contractors, permitting processes and delivery teams.
• Oversee Drug Substance infrastructure including biologics and small molecule facilities, cleanrooms and utilities.
• Direct and mentor site Project Managers to align with global standards and stage-gate processes.
• Resolve supply-chain constraints and design changes with risk-based engineering decisions.
• Partner with QA, Regulatory and Commercial Ops to ensure assets are commissioned for FDA PAIs and technology transfers.

Skills

Capital project leadership

CDMO industry experience

US market experience

Vendor/Contractor management

Regulatory/compliance knowledge

Education

Bachelor’s degree in Chemical Engineering or related engineering

Master’s degree in Chemical Engineering or related engineering

Job description

Do you want to lead a regional portfolio of complex Drug Substance capital projects across the US?

Are you experienced in turning global engineering concepts into fast, compliant and commercially focused project delivery?

Can you lead project teams and contractors to deliver high-value pharmaceutical facilities against demanding cost and schedule targets?

Fraser Dove International is partnering exclusively with an established life science manufacturing organisation. Operating across the US, they are committed to delivering high-quality manufacturing capacity through safe, compliant and efficient capital investment.

Our client is seeking a solution-oriented project leader to direct the regional Drug Substance capital project portfolio across its US manufacturing network.

Discover more about our Regional Project Head, US opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Regional Project Head, US, you will be measured against the following objectives:

• Deliver the regional Drug Substance capital project portfolio safely, compliantly, on time and within approved budgets, while meeting commercial capacity requirements.
• Establish strong project controls, stage-gate governance and contractor management to improve delivery speed, manage change and protect project value.
• Build aligned, high-performing project teams that deliver facilities to global engineering standards and support successful commissioning, qualification and validation.

What you will do:

As the Regional Project Head, US, your duties and responsibilities will include:

• Lead the execution of greenfield and brownfield Drug Substance capital projects across US manufacturing sites, ensuring projects meet agreed schedule and budget targets.
• Drive fast-track project schedules, project controls, budget tracking, stage-gate controls and change-order governance to support commercial capacity targets.
• Manage US Engineering, Procurement and Construction (EPC) and Engineering, Procurement and Construction Management (EPCM) contractors, permitting processes and internal and external project delivery teams.
• Oversee the delivery of Drug Substance infrastructure, including biologics and/or small molecule facilities, cleanroom environments, process equipment and utility systems.
• Direct, mentor and align site Project Managers and engineering teams, ensuring local project execution follows global engineering standards and stage-gate processes.
• Resolve supply-chain constraints, labour challenges and technical design changes through practical, risk-based engineering decisions.
• Partner with Quality, Regulatory and Commercial Operations teams to ensure assets are built and commissioned through Commissioning, Qualification and Validation (CQV) to support US Food and Drug Administration (FDA) Pre-Approval Inspections (PAIs) and client technology transfers.

What you will bring:

These are the skills and experience you will need to succeed as the Regional Project Head, US:

• 10+ years of progressive capital project leadership experience within the pharmaceutical, biotechnology or Contract Development and Manufacturing Organisation (CDMO) industries, with a strong focus on the US market.
• Proven experience delivering complex greenfield and brownfield Drug Substance manufacturing capital projects against demanding schedules and budgets.
• Strong technical experience in Drug Substance facility construction, including biologics upstream/downstream operations and/or small molecule synthesis, cleanrooms and utility systems.
• Strong knowledge of current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA) requirements, FDA expectations and relevant US building codes.
• Proven matrix leadership skills, with the ability to influence site leaders, manage contractors and develop project and engineering teams.
• Bachelor’s degree in Chemical Engineering, Bio-engineering, Mechanical Engineering or a related engineering discipline.
• Master’s degree in Chemical Engineering, Bio-engineering, Mechanical Engineering or a related engineering discipline.

Got what it takes?