Business Analyst

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

As one of the liaisons between IT and its clients, the Business Analyst is responsible for identifying the business needs of clients and stakeholders to help determine technology solutions to business problems and is accountable for Quality Assurance to ensure that all requirements have been successfully tested in the resulting technology solution. The Business Analyst works with project leaders to identify and define business issues, to build business cases, and lead the development of the Functional Requirement Specification (FRS). This role will also be responsible for leading those activities associated with the project that ensure quality of the end technology solution. As part of this role, the Business Analyst will also be engaged, as needed, in ongoing production support activities to enable timely and efficient resolution of system issues and recommend improvement opportunities. The Business Analyst will have regular direct interaction with Directors and other stakeholders in the Client organization.

Key Responsibilities include, but are not limited to:

• In partnership with the VP of IT, IT Program Manager, Architecture and the IT Governance team members as needed, facilitate the concept phase for all IT-enabled initiatives.
• Document current and future state business process and information flow maps
• Perform root cause analysis to identify current state process inefficiencies
• Develop qualitative and quantitative business cases for process improvements.
• Support business assessment reviews, Kaizen events and walk-throughs for Strategic initiatives.
• Develop detailed functional requirement specification from high level business concepts for business application development.
• Lead the development of Quality Assurance Plans to set quality parameters and expectations for deliverables across all phases of the Systems Development Life Cycle.
• Lead the development of Test Plans and Test Scripts that can be traced back to functional requirement specifications and ensure that all requirements are tested
• Support User Acceptance Test (UAT) activities to ensure quality of the end user deliverables
• Coordinate end user training program development
• Track realization benefits for IT investments
• Gain knowledge, as it relates to client business processes and support the ongoing development and maintenance of the Vaccines IT Strategy.
• Provide project management support for small and medium size local IT projects.
• Assist in the business process redesign and documentation as needed for new technology

Education & Experience:

• B.S., B.A, or M.S. in Information Technology, Science, Engineering or related field
• 5 or more years of experience as a Business Analyst in a corporate IT department
• Proven record of proficiencies associated with business analysis on small sized projects.
• Excellent understanding of cGMP's and System Development Life Cycle methodologies.
• Excellent facilitation, problem solving, and decision-making skills.
• Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
• Excellent written and oral communication skills.
• Working knowledge of the regulatory requirements for pharmaceutical applications

Desired:

• Proven facilitation, meeting/workshop management, project management and change management skills.
• Experience in Process Data Analytics
• Understanding and application of LEAN/MPS principles

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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