Immunomedics, Inc.

  • Senior Business Analyst, CMC and Operations

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(9/20/2019 12:09 PM)
    Job ID
    # of Openings
    Information Technology
  • Overview

    The Senior Business Analyst is responsible for business analysis within the CMC/Operations business technology area, supporting global Supply Chain, Manufacturing, Quality, and other Operations support functions.  The position is responsible for overseeing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business issues.  This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of the business processes key to CMC/Operations.  The Senior Business Analyst works closely with key business stakeholders, SME’s, IT peers, validation and other team members to identify and document business requirements needed to identify possible solutions for data, processes, interfaces, controls, systems, outputs, etc.

    The Senior Business Analyst, CMC and Operations will work in partnership with other domain business analysts in the development of best practices, standardized templates and business analyst methodologies to be practiced across the organization.


    • Participate as a Business Requirements Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.
    • In partnership with the domain IT lead, drive a portfolio of information system initiatives, programs, projects and services to optimize business process solutions within the domain.
    • Promote a culture of knowledge sharing across domains and engage in initiatives to proactively support sharing of best practices, templates and methodologies with fellow business analysts.
    • Provide industry and domain specific best practices perspective and consultation to business and IT partners.
    • Establish strong working relationships with business stakeholders to understand the business priorities and support activities to achieve them; be an engaged partner in the business domains success.
    • Build effective working relationships and collaborate with other domain and enterprise resources to ensure customer needs are being met.
    • Promote collaboration and teamwork within the domain and across IT.


    • Bachelors’ degree in Computer Science, Business or closely related field from accredited college or university, or equivalent experience
    • Minimum of 5 years relevant work experience as a business analyst, including hands-on experience with domain systems (i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations
    • Minimum of 5 years relevant work experience in global pharmaceutical/biotech organizations
    • Strong knowledge of Supply Chain, Manufacturing, and Quality operations and processes
    • Experience in and awareness of emerging business process automation trends and tools
    • Detailed knowledge of current Good Manufacturing Practices, Computer System Validation requirements (i.e. 21 CFR Part 11, Annex 11) and GAMP 5
    • Experience with computer system testing / Quality Assurance practices
    • Ability to prioritize and manage unrelated concurrent assignments
    • Effective time management skills with demonstrated ability to meet deadlines
    • Strong customer orientation and results focused with an attention to detail
    • Cross-functional agility and the ability to thrive in a complex and dynamic environment
    • Maintains direction and focus through proactive planning and organized approaches to work
    • Develops and implements innovative and creative solutions to business problems
    • Communicates a "can do" attitude and positive outlook, demonstrating initiative and resourcefulness
    • Certification / experience in Operational Excellence / Six Sigma highly desired
    • Business Analyst certification (i.e. CBAP) is highly desired
    • Domain Knowledge: Understands the pharmaceutical/biotech industry and how it operates; Demonstrates strong domain knowledge and how technology solutions can improve or enhance existing processes and overall business results; well versed in global GxP and Computer System Validation practices; solid understanding of the regulatory environment and industry standards (i.e. 21 CFR Part 11, Annex 11, GAMP 5, etc.).
    • Business Requirements Analysis / Documentation:  Defining, documenting, and communicating business requirements needed to support technical enhancements.
    • Process Design / Re-Engineering:  Analyzing design of business workflows, recommending changes to business processes under the framework of the domain goals; good at figuring out and documenting the processes necessary to accomplish domain business objectives; can simplify complex processes; understands how to separate and combine tasks into efficient processes.
    • Test Strategy Definition:  Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDLC.
    • Creativity: Capable of generating new and unique ideas to address business opportunities; easily makes connections among previously unrelated notions; tends to be seen as original and value-added in brainstorming settings.
    • Brainstorming:   Can facilitate effective brainstorming; can project how potential ideas may provide solutions for business needs; able to effectively communicate an idea and drive alignment.
    • Dealing with Ambiguity:  Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; remains calm, effective and practical when dealing with ambiguity; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
    • Multi-Tasking: Able to work on multiple, unrelated initiatives at the same time; can see opportunities for synergy and integration across subject areas.
    • Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization




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