Dir, Capital Projects

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 unlock the power of gene therapy to accelerate healthcare transformation.

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

The Project Director, Capital Projects at Spark Therapeutics will lead all day to day management aspects of large strategic capital projects including: pre planning (feasibility and capital funding approval), planning phase (through Basic Design) and the execution phase (detailed design/construction/commissioning/qualification) as well as project controls oversight through turnover to the lead end user. 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 for capital project portfolio.

Responsibilities

Build the requisite project team to include key stakeholders that will support all aspects of project delivery including Safety/EHS, Project Controls, Engineering, Design, Construction, Commissioning, Qualification, and Validation. This will include overseeing the selection and contracting of the Engineering/Procurement/construction/CQV resources.

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.

Education and Experience Requirements

• BS/MS in Engineering or related field required.
• 15 years of experience in the Biotechnology or Pharmaceutical industry strongly preferred
• Experience in project delivery within the biopharmaceutical environment GCP/GLP/GMP)
• Proven track record in delivering Capital Project Portfolio in the range of $100-$200M, and leading a Project Team of internal FTE's and outside contractors that would exceed 50 people.
• Have managed large capital projects through the entire capital project management lifecycle from Concept Design through Construction, Commissioning, Qualification and Start-Up.
• Demonstrated technical senior level project management experience to develop project goals, budgets, deliverables and timelines on large capital projects up to $200M and demonstrated ability to deliver on all aspects of Scope/Cost/Schedule.

Key Skills, Abilities, and 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 design.
• 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

Complexity and Problem Solving

• Ensure resolution to all organizational, technical and quality/compliance issues of process designs in GMP regulated facilities
• Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.

Internal and External Contacts

Accountable to all business units requiring capital projects

Internal Contacts - QC, QA, Facilities, Manufacturing, Supply Chain, MS&T, Finance, R&D

External Contacts - Vendor ecosystem for designing, building and starting up Greenfield GMP /Clinical manufacturing and research laboratory facilities.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $169,000 to $253,400.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.