Associate Director, OT Integration Solutions

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

The Associate Director, OT Integration solutions will provide direction and lead delivery of Spark operational technology (OT) data integration platforms and solutions. This role will be actively involved in project delivery and management of matrix teams including staff, contractors, and third-party partners to deliver new capabilities across manufacturing business processes. The individual will set the overall direction for the technical design, delivery, and scaling of the data integration platforms at Spark. The role will collaborate and partner with the key business stakeholders including Operations, Quality, and IT. The role will function as an internal advisor and visionary on emerging technologies and their application to our emerging field of Gene Therapy and be an integral part of developing the overall Digital Strategy for the Patient Supply Organization.

In this dynamic role, the successful candidate will blend expertise in process automation, data management, and industrial data integration within a gene therapy manufacturing environment. This position requires a blend of technical acumen and strategic thinking to ensure efficient, secure, and scalable digital systems that support advanced manufacturing and engineering processes in the rapidly evolving field of gene therapy. The operational technologies in scope for the role will include (but not limited to) the following:

• Emerson DeltaV for process automation
• Aveva PI data historian for robust data collection and analysis
• Industrial Internet of Things (IIoT) platform components, including messaging brokers, data operations, and Edge to Cloud streaming solutions.
• Unified Namespace and event driven architecture design principles for organizing and accessing data across various manufacturing systems.

Responsibilities

Strategy:

Provide vision, leadership, and direction for the overall manufacturing system landscape to ensure the new capabilities contribute to the company strategic goals. Develop a roadmap, business cases, and functional requirements for project execution. Evaluate technology concepts and designs to inform platform selection and validate business strategy aligned investment planning. Obtain stakeholder feedback and execute on governance to introduce new innovative technologies.

Execution:

Create and update delivery plans in a timely manner. Clear communication of project deliverable status, risks, and opportunities to stakeholders. On time in full delivery of milestones to ensure business objectives and value capture. Leverage agile development principles, in accordance with Corporate IT standards.

Leadership:

Manage team of contractors and third-party vendors to deliver on all project activities. Delegate responsibilities, provide oversight, and execute problem solving activities to build an accountable and effective delivery culture. Identify improvement opportunities to existing processes, equipment, and infrastructure.

Collaboration:

Build strong relationships with the external vendors and industry forums to understand trends and adjust capacity to deliver business value. Manage development of new contracts and adherence to existing contractual commitments.

Compliance:

Collaborate with Corporate IT to ensure all aspects of the software delivery lifecycle are executed in accordance to Spark IT principles, policies and standards. Specifically, policies related to security, privacy, architecture, and operations.

Education and Experience Requirements

• BS/MS/PhD in Life Science/Engineering or related field.
• Minimum 10 years of experience in the Biotechnology or Pharmaceutical industry working with manufacturing applications.
• Minimum 10 years of direct supervisory experience of technical professionals and staff with demonstrated effectiveness in providing guidance and coaching to deliver technology projects.
• Experience in biopharmaceutical based GCP/GLP/GMP environments including direct experience in design, build, test, and support of manufacturing systems.
• Practical knowledge of industry automation standards ISA 95 and ISA 88.
• Demonstrated planning and delivery of complex projects in a pharmaceutical manufacturing environment.
• Demonstrated project management experience including developing project goals, budget, deliverables, and timelines.
• Knowledge of software quality management including Good Manufacturing Practice (GMP) compliance, validation, change control, and data integrity.

Key Skills, Abilities, and Competencies

• Pharma4.0 knowledge, including translation of business strategies and processes into a technology vision.
• Develop and deliver a roadmap to deliver the vision and remain current on industry trends.
• Process and Building Automation Systems, Data Historians, Internet of Things, Finite Production Scheduling, and system integration platforms.
• Demonstrated ability to prioritize and coordinate activities within matrixed delivery team. Anticipate issues and complete proactive mitigations to exceed desired results.
• Develops stretch goals and effectively motivates teams, fosters a culture of continuous improvement and agile execution.
• Participates in the budget development process; effectively manage spend within their influence. (Statements of Work, Software Licenses, T&E)
• Ability to leverage critical thinking skills, prepare contingency plans, and influence in a complex project delivery environment.
• Ensure resolution to all organizational, technical, compliance issues across manufacturing systems.
• Erroneous decisions or failure to achieve results may delay business value return and have financial implications.
• Accountable to the Patient Supply Organization
• Represents the organizational unit as primary contact on vendor engagements and contracts.
• Interacts with equivalent level managers across functions including Manufacturing, Process Engineering, Capital Governance, Quality, and Corporate IT.
• This role may require travel, but it is infrequent and for a short duration. Hybrid working with minimum three days on the office required.
• Responsible and detail-oriented working practice is required. Ability to prioritize work stream to meet complex deadlines for multiple simultaneous projects.

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 $147,100 to $220,700.

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.