Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)

Role Summary

The Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing) in the PDM IT organization will be a strategic technology partner to the PDM Biologics Clinical Manufacturing business capability, aligning technology direction with business goals and defining effective solutions while maturing existing systems and services to drive business value. The role oversees ideation, planning, and development for the Biologics Clinical Manufacturing capability, participates in short- and long-term IT strategy and business case analyses, and leads a mix of internal and contracted teams to deliver outcomes.

Responsibilities

• Cultivate working knowledge of Biologics Clinical Manufacturing, Facilities & Engineering, and Quality Control.
• Participate in strategic planning to improve business or IT processes through capability development.
• Lead discovery sessions to identify opportunities and propose cost-effective solutions; develop business cases with resource estimates and ROI models.
• Advise on options, risks, costs vs benefits, and impacts on end-users, processes, and systems.
• Establish and maintain strategic relationships with leadership and senior stakeholders.
• Drive IT solutions planning for Digital Strategy initiatives from ideation to execution, including SaaS and other applications; prioritize across initiatives.
• Collaborate with IT leadership to manage the application portfolio and lead internal and contracted services staff to drive outcomes.

Qualifications

• Required: Bachelor’s degree with 5+ years of relevant experience; or Master’s degree with 3+ years of relevant experience; degree in computer science, information sciences or related field or equivalent experience.
• Preferred: Strong understanding of GxP compliance and 21 CFR Part 11; significant IT experience in biopharmaceutical environments; experience with IT implementations, integrations, cloud transformations, and data security/compliance in healthcare settings; knowledge of Biologics Clinical Manufacturing processes; ability to translate technical topics into business terms.

Skills

• Excellent communication, research, and learning agility; strong collaboration and stakeholder management; ability to listen and understand business needs; strong multitasking and deadline management in a matrix organization.
• Analytical thinking, problem-solving, and capability to drive strategic IT governance and delivery; experience with Agile methodologies and tools (e.g., Jira, Asana); programming experience (Python, R) and cloud platforms (AWS) is desirable; awareness of GenAI, Digital Twin, AI/ML trends relevant to biopharmaceuticals.

Education

• Bachelor's degree required; 5+ years of relevant experience or Master’s degree with 3+ years of relevant experience. Degree in computer science, information sciences or related field or equivalent experience.

Additional Requirements

• Experience with platforms critical to Biologics Clinical Manufacturing (e.g., MES, Electronic Batch Records, ERP Mfg, CMMS, Digital Process and Automation, Historian, IoT) and willingness to adapt to new IT systems.