Director, Capital Projects

Paragon Bioservices   •  

Harmans, MD

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 78 days ago

This job is no longer available.

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon’s scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.

The Director, Capital Projects will have scope and responsibility for the planning and delivery of capital project scopes by managing a team of internal and external resources; tracking project performance against established targets (cost, schedule, and quality); monitoring, controlling and reporting on project status including risks and issues; and ensuring the successful delivery/return of the facility, equipment and/or system(s) to routine operations. These projects will be varied and supporting GMP manufacturing, laboratory and administrative operations of the company.

Key Responsibilities include but are not limited to:

Project planning – Work with functional area representatives to develop plans to successfully implement project scope while optimizing resource investment and risk tolerance. Balance project risk and uncertainty through risk management and mitigation plans. Develop or arrange development of cost and labor estimates as well as implementation timelines.

Project initiation – Work with project sponsors, stakeholders, clients and solution providers to identify business drivers, project objectives and project requirements utilizing best practices through work plans, critical path analysis and earned value milestones. Ensure safety and environmental measures are taken and appropriately addressed throughout the projects

Project implementation – Oversee all design, procurement, development, fabrication, installation and testing of all facility systems and utility equipment as specified and in accordance with all project requirements

Oversee the preparation and hand-over to end users to enable successful operation of newly installed systems and equipment

Education & Experience:

  • Minimum of 7 years of experience working in GMP or a regulated environment with some or all of this experience leading multi site Capital Projects
  • BA/BS degree in Construction Management, Engineering, or related field required. An advanced degree and professional certification are a plus
  • Experience leading teams both directly & indirectly.