Director, Facilities & Maintenance Operations

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.

Primary Duties

Spark Therapeutics is seeking a highly skilled and experienced Director, Facilities Maintenance & Operations with a strong background in Good Manufacturing Practices (GMP) to lead our maintenance and operations team. The ideal candidate will have a proven track record of managing complex maintenance and operations processes in a biopharmaceutical or pharmaceutical research & manufacturing environment. This role is critical in ensuring the reliability, compliance, and efficiency of our research & manufacturing facilities.

Responsibilities

• Leadership & Strategy

• • Responsible for directing and overseeing the Spark Therapeutics maintenance organization across several facilities, including 3737 Market, 3025 Market, 3000 Market, Vivarium, Discovery Labs, and GTIC. Primary responsibilities include managing and coordinating both managed and soft services, such as facility and equipment upkeep, GMP cleaning, and oversight of managed services providers, while constantly driving for continuous improvement.  Scope will include GMP, GLP, Office and Warehouse Environments.
  • Develop and implement maintenance and operations strategies that align with the company's goals and GMP requirements
  • Provide visionary leadership to the maintenance and facilities team, fostering a culture of excellence, safety and compliance.
  • Collaborate with cross-functional teams to optimize research and manufacturing processes and ensure smooth operations.
  • Collaborate with the Head of capital and the Business Capital Lead to develop and execute the capital lifecycle program, ensuring effective planning, implementation, and management of capital projects.

• GMP Compliance
  • Oversee and ensure compliance with GMP regulations and guidelines to maintain the highest quality standards in production.
  • Implement and maintain Standard Operating Procedures (SOPs) related to maintenance and operations in accordance with GMP/GLP standards.
  • Conduct regular audits and inspections to identify and rectify any compliance gaps.
  • Establish and implement a comprehensive Spark Therapeutics Reliability Program. This encompasses the development of an asset management strategy, maintenance strategy, proactive management of recurrent equipment issues (Bad Actor Management), optimization of preventive maintenance and spare parts inventory, and a strategic shift from preventive to predictive maintenance methodologies.

• Maintenance Management
  • Ensure the drive for equipment reliability, reduction in unplanned downtime, and improvement of Overall Equipment Effectiveness (OEE) within manufacturing operations by making strategic adjustments to the asset management plan, maintenance plans, and the implementation of predictive and preventive maintenance programs.
  • Develop a forward-looking, 5-year spare parts strategy anticipating asset growth. Develop a spare parts management system, maintain optimal spare parts stock based on risk-based analysis considering equipment criticality and condition.
  • Collaborate with external vendors and contractors as needed for specialized maintenance projects.
  • Serve as the principal business owner for the CMMS (Computerized Maintenance Management System) leading the process of evaluation, selection, and implementation of a new system to replace the existing Procal system. Responsibilities include defining user requirements in partnership with MS&T and maintenance divisions, system requirements, collaborating with the IT department for system integration, and developing new processes to optimize system usage for maximum efficiency in Maintenance Operations. Look to IT solutions to track and log critical quality attributes for franchise brands.
  • Review, modify and implement work order management, maintenance, and calibration policies and procedures.

• Operational Efficiency
  • Continuously improve operational efficiency by identifying and implementing cost-effective solutions and process improvements. 
  • Develop and implement Maintenance and Reliability Key Performance Indicators (KPIs), including leading indicators, such as Mean Time Between Failures (MTBF), Mean Time To Repair (MTTR), equipment availability, and overall equipment effectiveness (OEE).
  • Foster a culture of continuous improvement within the maintenance and facilities team.

• Budget Management
  • Develop and manage the maintenance and operations budget, ensuring efficient allocation of resources.
  • Identify cost-saving opportunities without compromising quality or compliance.
  • Develop and execute Spark's Asset Investment Management Program (AIMP), featuring a rolling 5-year profit maintenance capital expenditure plan for site facilities and equipment. This will serve as a crucial input for the annual business capital plan. Additionally, support the formulation of annual capital plans and budgets in alignment with the asset management investment program strategy.

• Safety and Environmental Compliance
  • Ensure facilities meet EH&S requirements and legal compliance. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies.  Drive a culture of "Safety First" throughout the maintenance organization.
  • Stay current with industry trends and regulations related to safety and environmental standards.
  • Prioritize safety and environmental compliance, implementing best practices and ensuring all team members adhere to safety protocols.
  • Drive a Spark-wide Sustainability Program for Energy Savings and reduced carbon footprint savings in collaboration with Spark EHS and deliver sustainability projects across scientific and manufacturing locations.

• Team Development
  • Lead, develop, train and certify high-performing maintenance teams across facilities, prioritizing customer needs and striving for high customer satisfaction, equipment and facility reliability, and continuous improvement. Promote the utilization of the CMMS for essential functions such as work order management, preventive maintenance and calibration scheduling, and bad actor management. Additionally, maintain expertise in FDA, EU, safety, state, and local regulations to ensure compliance and adherence to relevant standards.
  • Provide regular feedback, coaching, and mentorship to team members to encourage their professional growth.
  • Provide leadership for enhancing the reliability and maintainability of equipment, processes, utilities, facilities, as well as mechanical, electrical, and safety/security systems during the design and execution phases of capital projects.

Education and Experience Requirements

• A minimum of 15 years of experience in progressively more responsible leadership positions in Facilities, Engineering or Manufacturing within the biopharmaceutical or pharmaceutical industry.
• Minimum of Bachelors Degree, (Advanced Degree preferred) in Operations Management, Engineering, or related field
• Strong knowledge of Good Manufacturing Practices (GMP), Good Lab Practices (GLP) and regulatory requirements.

Key Skills, Abilities, and Competencies

• Safety-Conscious mindset
• Budget management experience
• Must have direct experience/involvement in Regulatory inspections (multi-authority)
• Must have direct experience authoring relevant sections of Regulatory submissions and responding related to Information Requests
• Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines.

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.