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IT Lab Informatics COE Leader

Date: Feb 22, 2021

Location: Philadelphia, 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 Lab Informatics COE Leader will collaborate closely with business leaders to understand business strategy, demand, and priorities and help the business deliver projects that leverage Lab Informatics solutions aligned with the overall business and technology strategy.  The Lab Informatics COE Leader is the main point of contact with business stakeholders for implementation and support of LIMS and ELN applications.  He/She will be responsible for leading a team to support Lab Informatics applications and stakeholder relationships, as well as participate in road-mapping for future upgrades and implementations.  This includes gathering and analyzing data in support of business cases and proposed projects. This individual will apply advanced communication, analytical, and problem-solving skills to help maximize the benefit of Lab Informatics investments across the company.

 

RESPONSIBILITIES:

 

30%  Strategy & Planning

  • Contribute to and execute the business roadmap for Lab Informatics Applications (LIMS, ELN, SDMS, LES) and related applications and technologies.  Collaborate with business system owners, business stakeholders and the IT Business Partner to ensure demand is prioritized.  Collaborate with Enterprise Architecture to ensure projects and solutions are aligned with Spark architectural principles and strategic goals. 
  • Partner with business functions to identify process gaps and recommend solutions. Review and analyze existing LIMS and ELN applications for effectiveness and efficiency, and then develop strategies for improving or leveraging these applications.  Analyze business scenarios and identify opportunities for improvement through automation and/or business process redesign. 
  • Recommend application-usage best practices and solutions based on Spark’s specific needs. 

 

20%  Acquisition & Deployment

  • Research and make recommendations on Lab Informatics application products and services in support of portfolio management and procurement efforts.
  • Evaluate proposals and Statements of Work to identify potential problem areas and make the appropriate recommendations.
  • Negotiate contracts with Lab Informatics software and service providers.
  • Collaborate with Program/Project Managers, Business analysts, Business System Owners, Key End Users, Business Process/Data Owners, and Implementation Partners on the implementation of new Lab Informatics applications. 
  • Ensure an orderly transition to operations by leveraging DevOps concepts for transitioning implementations to Operations/Support.
  • Take the lead role in managing relationships with Lab Informatics Vendors 

 

30%  Operational Management

  • Manage day to day and scheduled Lab Informatics application support; respond to application support issues from multiple business customers.  Work with managed support teams to work issues to resolution with a high level of quality and stakeholder satisfaction.
  • Manage backlog of maintenance and enhancement requests.  Collaboratively groom and prioritize backlog with key business stakeholders.  Collaboratively plan and deliver maintenance releases with business system owners.  
  • Liaise with company’s software and support vendors for prompt rectification of any problems or emergencies. 
  • Lead team to ensure that the deployed applications are well documented with regards to process models, application configuration, and integration to facilitate road mapping and support.
  • Compile and maintain inventory of Lab Informatics application components and their corresponding contracts/agreements for license and support.
  • Lead team to develop and communicate training and documentation for end users, hold clinics as necessary, and other user-related activities.
  • Establish standards and processes for the Lab Informatics COE. Collaborate on the development and continuous improvement of Data Governance policies and guidelines.  Oversee the creation and quality of SDLC project deliverables including process and data models, requirements specifications, design, configuration, and testing (including validation deliverables). 
  • Enable Spark’s growth strategy by driving efficiency and agility in Lab Informatics application enhancement and platform management by leveraging vendor best practices, minimizing customization, and assessing IT trends within the organization. Serve as liaison for process, data, and application integration related decisions.
  • Develop, implement, and maintain policies, procedures, and associated plans for Lab Informatics software administration and appropriate use.
  • Produce deliverables that facilitate better understanding for feedback such as flow diagrams, data models, pros/cons, prototypes, wireframes and other illustrations.

 

20%  Leadership

  • Develop and execute a plan to build a Lab Informatics COE.  This new COE will be a high performance, efficient and effective team providing value across the business. 

 

REQUIREMENTS:

 

  • Bachelor’s degree in Computer Science, Chemistry, Biochemistry or related discipline or equivalent experience.
  • 10+ years of implementing and supporting Lab Informatics applications for Quality and R&D areas of life sciences companies. 
  • Experience automating and supporting scientific and experimental capabilities with Electronic Lab Notebooks
  • Experience driving sample-centric workflows and processes in LIMS applications
  • Experience leveraging Lab Informatics applications to drive business workflows and processes integrated with MES, ERP and QMS Applications in quality-manufacturing production environments
  • Experience evaluating and negotiating contracts and Statements of Work with Lab Informatics vendors as well as implementation/support vendors.
  • 3+ years of successful management experience.
  • Strong Computer System Validation experience.
  • Knowledge of Quality Assurance/Compliance, 21 CFR Part 11 and other FDA regulations required.
  • Proven IT project leadership and architectural skills, including the ability to gather and elaborate clear business requirements and develop business cases with clear value propositions. 

 

 

COMPETENCIES:

 

  • Ability to interact with senior leadership in establishing strategic plans, communicating status of key initiatives, including making recommendations and/or attempt to influence decisions in the best interest of the company.
  • Strong business acumen with significant business process and/or operational excellence experience, including establishing and managing relationships across all levels of the business.
  • Strong functional, organizational and communication skills, with a proven ability to effectively meet deadlines and milestones.
  • Understanding and utilization of best practice solutions to drive predictable outcomes.
  • Ability to effectively oversee and manage external partner relationships, contracts, and service agreements.
  • Ability to model business processes and application data flows to clarify requirements and facilitate design.
  • Ability to analyze and define business requirements and translate into technical solutions.
  • Effective project management skills are essential; change management capability and desire to innovate and help lead change.
  • Proven adaptability to shifting project schedules, priorities, and assignments; able to make effective decisions under pressure.
  • Demonstrated self-directed, problem solver in a dynamic, fast-growing, fast paced, team environment.
  • Exceptional analytical, conceptual, and problem-solving abilities.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Ability to communicate ideas in both technical and user-friendly language.
  • Experience working in a team-oriented, collaborative environment.
  • Desktop Application literacy required; MS Office skills (Outlook, Word, Excel, Sharepoint)
  • Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), and other regulatory requirements or policies.

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Nearest Major Market: Philadelphia