Senior Manager, Capital Projects

Samsung Biologics•Rockville, MD

1d•$140,000 - $186,000•Onsite

About The Position

Samsung Biologics’ biopharmaceutical manufacturing site in Rockville is seeking a Senior Manager of Capital Projects. This role is responsible for leading large, complex facility and equipment improvements, overseeing the planning and execution of large-scale capital projects. The Senior Manager will manage scope and schedule within the agreed business case, keep the team focused on the execution plan, and ensure the portfolio aligns with the long-term Facility Master Plan and site growth strategy. This position provides oversight of technical teams, shutdown PM, and schedulers, offering day-to-day guidance on specific project deliverables and acting as an escalation point for project impediments. The role involves developing high-level risk mitigation strategies to protect the project’s critical path and ensure a successful shutdown and startup of the facility. Accountability for project budgets includes developing funding strategies, managing cash flow, and providing monthly latest best estimates to senior leadership. The Senior Manager will lead Project Steering Committees/Stage Gates, follow PMF best practices, and serve as the point of contact for site leadership and sponsors, translating complex project data into actionable business insights. Defining the procurement and execution strategy (e.g., EPC, EPCM, or Design-Build) and leading the selection and management of top-tier Architecture & Engineering firms and Construction Management companies are key responsibilities. The role also champions Safety by Design and construction safety, ensuring adherence to OSHA standards and cGMP regulatory requirements throughout all project phases. Collaboration with key stakeholder groups including Production, Supply Chain, Regulatory, Validation, Automation, Quality, Metrology, Maintenance, and MSAT is crucial for on-time, within-budget, and within-scope project delivery.

Requirements

Bachelor’s degree in engineering discipline (Chemical, Mechanical, Biological or similar)
10 years or more of relevant experience working in a regulated cGMP biopharmaceutical environment.
Working knowledge of biopharmaceutical production, quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes.
Project management experience, including the ability to manage a project by delivering scope, cost and schedule.
PMP (Project Management Professional)
CCM (Certified Construction Manager)
Capable of working in a collaborative and team focused environment.
Demonstrated understanding of ASME BPE and ISPE guides

Responsibilities

Lead large complex facility and equipment improvements.
Oversee the planning and execution of large-scale capital projects.
Manage scope and schedule with agreed business case.
Keep team focused on execution plan.
Ensure that the portfolio aligns with the long-term Facility Master Plan and site growth strategy.
Provide oversight of technical teams, shutdown PM and scheduler.
Provide day-to-day guidance to team on specific project deliverables.
Act as escalation point for project impediments.
Develop high-level risk mitigation strategies that protect the project’s critical path as well as delivering a successful shutdown and startup of facility.
Accountable for project budgets, including developing funding strategies, managing cash flow and providing monthly latest best estimates to senior leadership.
Lead the Project Steering Committees / Stage Gates and follow PMF best practices.
Serve as point of contact for site leadership and sponsors, translating complex project data into actionable business insights.
Define the procurement and executing strategy (e.g. EPC, EPCM or Design-Build).
Lead the selection and management of top-tier Architecture & Engineering firm and Construction Management companies.
Act as ultimate escalation point for project impediments.
Develop high-level risk mitigation strategies that protect the project’s critical path and the plant’s commercial supply.
Champion Safety by Design and construction safety.
Ensure every project phase – from breaking ground to final validation – adheres to strict OSHA standards and cGMP regulatory requirements.
Collaborate with key stakeholder groups including Production, Supply Chain, Regulatory, Validation, Automation, Quality, Metrology, Maintenance and MSAT to ensure project is delivered on time, within budget and scope.