The Project Director, Technology Capital Projects at Spark Therapeutics will lead all day to day management aspects of our major capital project for the Spark GTIC Project 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 - $1 B).
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 End User Requirements, 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.
Collaborate with numerous cross functional teams within the Spark Technology Development Organization (Manufacturing, Digital Systems, MS&T, Process Development, and Quality) to ensure all facility and process assets are ideated, evaluated and selected, approved, constructed, delivered and supported in accordance to Spark IT principles, policies and standards.
- BS/MS in Chemical or BioChemical Engineering or related field required.
- Minimum 25 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 $500 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.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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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.