Senior Manager, Capital Projects

Join Samsung Biologics’ biopharmaceutical manufacturing site in Rockville, as the Senior Manager of Capital Projects. The Senior Manager’s function at the Rockville site is to be responsible for leading large complex facility and equipment improvements.

• Oversee the planning and execution of large-scale capital projects. Manage scope and schedule with agreed business case and 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. This includes developing funding strategies, managing cash flow and providing monthly latest best estimates to senior leadership to ensure projects remain fiscally responsible.

• Lead the Project Steering Committees / Stage Gates and follow PMF best practices. You will be 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.

Qualifications:

• 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