|Looking for an IT Business analyst with, will gather user requirements, write up system design specs, write up functional requirements, interviewing users and generating documentation, will be fairly seasoned and work independently with the customer. This is for a LIMS implementation, implementing a new software package for lims, so exp with a LIMS implementation in the past is required, labvantage is the 3rd party software vendor so exp with this is nice to have. They will have to work in a team environment, guide the tech lead on some of the build out of the system, we expect if they have worked in lims then previous pharma industry is required, gene therapy specific is preferred. BS degree required. Experience working with different Managers with different levels of expertise.|
Duration – 1 year, possible extensions
Interview – 2 Virtual
Business Analyst LIMS/Gene Therapy Development
Has been asked to provide services at MA to support a LIMS implementation for a Quality Control lab that specializes in Gene Therapy development. The specific LIMS workflow is Sample Management and Inventory Management.
The appropriate individual will have a BS in a scientific discipline and 10+ years of experience with Biologics development working in BioTech companies, with specialization in the Gene Therapy area.
Clear evidence of strong communication skills, strong interpersonal skills and the ability to work constructively with colleagues with all levels of Gene Therapy development is required.
• Work with scientists to create, mature and develop standards for workflows across laboratories and laboratory processes
• Generate documentation in accordance with GMP practices for all Business Analysis related aspects of the implementation including but not limited to Business Requirements, Functional Design Specification, Requirements Traceability Matrix, Functionality Test Plans
• Work on premises to learn and map current state work processes and workflows
• Generate benefits model demonstrating business value of modified processes
• Work with Technical Lead on Freezer monitoring and management business requirements
• Define the business requirements for inventory data migration between current state and future state systems
• Work closely with QC & Validation specialists to meet all GxP Validation requirements
• Deliver to aggressive timelines
• Work with the Technical Lead to develop training materials for application use, and in lab workflows
• Sets work expectations with customers and delivers against them
• Familiar with software deployment and development life cycles
• Possess excellent customer consulting, written and communication skills
• Has knowledge/education in the Life Sciences and/or Information technology disciplines with specialization in Gene Therapy development and BioTech companies.
• Bachelor's degree in Computer Science or relevant degree or work experience
• Experience with Biologics Development Sample Management and Inventory Management
• Experience with LIMS systems use in Sample Management areas
• Experience with LabVantage LIMS preferred
• Functional knowledge of working in a GxP environment
• Strong MS Office skills, including Visio
• Demonstrated ability to learn new systems
• Ability to drive, and work well, in teams
• Strong communication skills and ability to lead discussions