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Technology Lab Digital Systems Lead

Date: Feb 16, 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.

 

 

 

Acting as the thought-leader around lab digital systems and new technologies deployed across the Technology organization, the Technology Lab Digital Systems Lead is accountable for delivering a scalable, responsive, adaptive lab digital systems landscape to enable the overall Technology strategy and overall integrated GxP systems architecture.  The role will collaborate and partner with the key business stakeholders across Technology and IT including Analytical Development, Process Development, Quality Control, Data Science, Automation, Manufacturing Science & Technology and Computer Systems Validation.  The role will act as an internal advisor and visionary on emerging laboratory technologies and their application to our emerging field of Gene Therapy and be an integral part of developing the overall Digital Strategy for Spark.  Systems in the scope of this role include:

 

  • LIMS Strategy and Project Execution
  • Electronic Lab Notebook (ELN), Lab Execution Systems (LES), and other lab workflow systems
  • Develop strategy and tools for paper-based documentation digitization
  • Lab instrument and automation systems
  • Digital systems supporting Data Integrity for Technology Labs

 

Partner with the Lab Automation and Data Science teams to define and execute a data engineering strategy to enable data science and advanced analytics and to support automation across the Technology organization.

 

 

Responsibilities

 

Build and provide leadership, vision and direction on the Lab Digital Systems to ensure they will contribute to the company achieving its goals. Drive business case definition / requirements for key projects and digital transformation. Evaluate conceptual aspects of technical designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.  Partner with Roche colleagues to leverage user requirements, designs and validation protocols to accelerate delivery for Spark.  Experience with LIMS Platforms (e.g. LabWare), Electronic Lab Notebooks, Lab Execution Systems, data analysis and lab informatics tools, Scientific Data Management Systems (NuGenesis), Process Data Systems (Riffyn), and validation tools (ValGenesis)

 

Ensure system implementation and enhancement plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Meet scheduled milestones to ensure project/program objectives are met in a timely manner. Use of agile development principles, in accordance to Corporate IT standards, where applicable.

 

Manage assigned staff through successful recruitment, performance management, development planning, and retention of a high performing team. Effectively delegate responsibilities to achieve group goals and align individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

 

Build strong relationships with the vendor ecosystem in order to understand trends and to build additional capacity to deliver business value. Manage development of new contracts and adherence to existing contracts, and leverage Roche MSA’s/Software licenses where applicable.

 

Collaborate with Corporate IT to ensure all Technology and enterprise information and technology assets leveraged by Technology are ideated, evaluated and selected, approved, constructed, delivered and supported in accordance to Spark IT principles, policies and standards for security and privacy, technology architecture, technology delivery lifecycle (e.g. SLDC, Agile), technology operations and Spark IT Operating, Delivery and Support Models. 

 

 

Requirements

 

  • BS/MS/PhD in Life Science/Engineering or related field required. 
  • Minimum 15 years of experience in the Biotechnology or Pharmaceutical industry.
  • >10 years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff. 
  • Experience in biopharmaceutical based GCP/GLP/GMP environments including direct experience in developing/deploying/supporting LIMS, ELN, LES, and SDMS in a GXP environment.
  • Proven track record organizing and delivering applications from concept to go-live.
  • Demonstrated technical project management experience to develop project goals, budgets, deliverables and timelines.
  • Knowledge of GXP compliance and experience with Data Integrity elements of the various systems.

 


Nearest Major Market: Philadelphia