Share this Job

Technology Capital Projects Leader

Date: Nov 19, 2020

Location: PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

The Project Director, Technology Capital Projects at Spark Therapeutics will lead all day to day management aspects of our major capital project for Project Gateway including: all design phases, engineering, project controls, construction, CQV through facility licensure. These elements include scope definition and control, stakeholder alignment, project planning, resource and risk management, project leadership, and team development, engineering and construction contractor management and communication throughout the organization. Successful capital project management includes guiding project team activities to meet project and business objectives, and approval of project recommendations through our project and capital governance processes. This role is responsible for establishing and managing the overall project schedules from design through construction, commissioning, qualification and start-up phases and manage the overall budget of this capital project (>$500MM).

 

Responsibilities

  • Hire team members to support Project Gateway Safety/EHS, project controls, engineering, design, construction, commissioning, qualification, validation and licensure.  The hiring plan will consist of hiring Spark FTE’s, contract SME’s, and various engineering and equipment firms. 
  • Leverage Roche resources where applicable and leverage facility design and equipment standards with key Roche Global Engineering colleagues.
  • Establish and manage the project scope and resulting estimates/budgets.Properly allocate funds across CAPEX and OPEX budgets and report through various project and corporate governance bodies
  • Coordinate requirements of federal and local governments with respect to zoning and planning related matters; manage all outside vendors and contractors supplying either engineering/construction services or equipment to the project
  • Develop, manage and maintain up-to-date project timelines inclusive of all critical milestones, key interdependencies and resource constraints, applying appropriate project scheduling techniques utilizing P6 scheduling tool
  • Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning

 

Education and Experience Requirements

  • BS/MS in Chemical or BioChemical Engineering or related field required. 
  • Minimum 20 years of experience in the Biotechnology or Pharmaceutical industry
  • Experience in biopharmaceutical based GCP/GLP/GMP environments
  • Proven track record in delivering large greenfield GMP Facility Capital Projects in the range of $400 MM and up, and leading a Project Team of internal FTE’s and outside contractors that would exceed 100 people.
  • Have managed large capital projects through the entire capital project management lifecycle from Concept Design through Construction, Commissioning, Qualification and Start-Up including facility licensure.
  • Demonstrated technical senior level project management experience to develop project goals, budgets, deliverables and timelines on large capital projects in excess of $300 MM and demonstrated ability to deliver on all aspects of Scope/Cost/Schedule

 

Competencies

  • Multiple examples of proven results showing day to day efforts managing large, complex Capital Projects and build ahigh performance team for major capital projects.
  • Adept at managing Architectural/Engineering, Construction Management, and key Equipment supplier teams/resources and translating user requirements into actual conceptual, basic and detailed designs
  • Adept at the overall bidding process throughout the project lifecycle and ability to work with Procurement for all the goods and services supplied to the project.
  • Demonstrated ability working with MS&T and Development groups to assist in developing scalable process designs to transfer into Clinical and Commercial manufacturing.
  • Experience in Regulatory Inspections, Good Manufacturing Practice (GMP), Change Control, Validation aspects of major capital projects.
  • Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
  • Experience utilizing Cost Control methodologies and firms to manage the overall project cost for the project.  
  • Ability to develops stretch goals and uses effective motivation techniques to achieve them.  Strong team diagnostic skill and strategy for team growth. 
  • Ability to motivate staff, foster a culture of continuous improvement and agile execution
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere