This is a hybrid contract for candidates that are located in Northern California and 100 % remote for candidates outside the area.
Direct W2 contractors only! No 3rd party agencies! We are not able to sponsor any H1B Visa!
Description
BA, Clinical Stage Cell Therapy Process & Analytical Development - Data and Analytics
The Business Analyst (BA) is a self-motivated expert in business analysis who is passionate about improving healthcare. They are flexible and dedicated to providing value to patients. The BA must be good at negotiating, leading, and communicating when working with the Cell and Gene Therapy business unit at client and with IT teams. The BA will collaborate with one or more internal business groups and IT teams to understand their main goals and needs. This will help IT teams create products that meet business needs and are valuable, stable, easy to use, and scalable. The BA will work on two main product areas within the Advanced Therapies Product Line. The first area is Bioinformatics Workflows & Cloud, and the second is setting up Genomics Capabilities, specifically an NGS Lab. The ideal candidate will bring their business analysis skills, knowledge of Agile Release Trains, experience in GxP-compliant environments, and expertise in Computer System Validation (CSV) to deliver regulated GMP IT products and capabilities. Responsibilities: Analyze/document current and future business process models, high-level requirements (scope), and detailed functional specifications or agile user stories with acceptance criteria.
Guide and support other Business Analysts and Product Managers as they develop the detailed requirements or agile user stories with acceptance criteria.
Lead/contribute to all acceptance testing efforts, including SAT, UAT, and dry runs.
Effectively communicate with the IT development team and the extended project team.
Independently make BA project decisions with impact at the process, organization, or program level.
Tailor messaging to different target audiences and choose appropriate communication channels.
Act as a Lead BA and/or Product Owner/Product Owner Delegate on large/global or multi-portfolio initiatives/projects.
Actively look for opportunities to improve how business processes are executed.
Skills required:
7 years plus experience as business analyst
Documented and proven experience with Solutions for Data Engineering and Data Curation, including an understanding of technology trends (e.g. solutions like Snowflake and Cloud-based solutions and development) and concepts (e.g. Data Mesh and Data Products, data governance and standardization)
Proven track record of engaging with new customers (esp. scientists) to understand and document business processes and requirements.
Substantial experience managing product roadmaps and product backlogs, supporting a product owner in managing an agile team's backlog, and prioritization. General:
Experience with Pharmaceutical Manufacturing Processes and Systems, ideally in the Cell and Gene Therapy space.
Experience with FAIR and Data Governance Concepts
Ability to interact with Scientists and to work with them on collecting their requirements
Experience with supporting the implementation of IT solutions that require GMP validation.
Experience with working as a member of an agile development team, proficiency with agile methodologies and concepts such as User Stories, Story Maps, Personas, etc.
Willingness to learn something new. Being curious and inquisitive, but also self-sufficient in acquiring knowledge
Grasping technical concepts and interacting with solutions on a technical level, e.g. making API calls with some guidance.
Pro-actively guiding and interacting with a demanding and very dynamic user community
Team player
Strong hands-on experience in deploying a broad set of technologies end-to-end.
Experience in and understanding of application development methodology, including Agile and Waterfall approaches, process modeling and re-engineering, user acceptance testing, organizational change management, and large-scale/global system implementations.
Excellent communication (written and oral) and presentation skills; solid business acumen; and well-honed influencing skills are essential.
Self-motivated and team-oriented; able to work both autonomously and effectively as part of a geographically dispersed team.
Comfortable working with Google collaboration tools.
Preference:
Very proactive, experience working with data systems that produce data, experience around manufacturing Understanding of the needs and operations of a Wet lab, including ELN and LIMS systems
Experience implementing IT solutions that need GMP validation
Experience working in an agile development team
Familiarity with agile methods and tools like User Stories, Story Maps, and Personas
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