Title: R&D Business Analyst
Why the role is open: Data integrity project 2, a system to biz users which is a combination (asset management system for large molecules). 2021, bring in another asset mgmt system. Create some services to link vendor products and automate testing.
What are the three big must haves: Someone with gene therapy. What are their assets and attributes. Working on LIMS systems. Agile experience. This is a non-gxp knowledge. Pharma background is really needed. CFR preferred, not needed.
Timeline/duration: 12 months
Location: Remote, then Cambridge
Interview process: Phone + Video
Most exciting pipelines in the Biotech / Pharmaceutical industry. Along with this growth comes several exciting opportunities to work with our expanding business areas. Within Research & Development (R&D) IT, there is a need to support an ongoing data integrity program as a contract Business Analyst.
S/he will be expected to partner with the R&D IT, R&D Business and cross functional teams to support a suite of systems.
The key activities for this position include:
Gathering and documenting requirements for Laboratory Information Management System (LIMS) implementations of registration and workflow management tools in support of biomaterial assets and biological assays (in vitro and in vivo)
Author SDLC deliverables
Author user stories with clear acceptance criteria and time estimates
Develop process knowledge to translate to business and technical requirements
Document business processes and use cases
Provide appropriate technical/functional software support throughout the life of the project
Assist in testing (functional, regression) and implementation of new application
Support development of training materials and facilitation of end user training
Contribute to the creation of operational support documentation
Determine systems retirement/data archiving requirements and execute via standard processes, as needed
Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
3 - 5 years' experience as a business analyst, with command of business analysis techniques and tools, as well as waterfall and iterative (agile scrum) systems development methodologies
Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction
Working knowledge of LIMS systems, SDLC, Agile, GxP, CFR 21 Part 11 and systems validation
Life Sciences, Biotech or pharmaceutical industry experience required.
Education: BA or BS required in a science or engineering field (Chemistry, Biology, Computer Science, Biological Engineering, or a closely related field)
Additional Job Requirements
ManpowerGroup is an Equal Opportunity Employer (EOE/AA)