Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)
Gilead Sciences
17 days ago
Remote friendly (San Francisco Bay Area)
United States
IT
Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing) — PDM IT
Responsibilities
- Be a strategic technology partner to the PDM Biologics Clinical Manufacturing business capability; align technology direction with business goals; define relevant solutions and mature systems/services to drive business value.
- Lead ideation, planning, and development oversight for the capability; participate in short- and long-term business/IT strategic planning.
- Support business case development (resource estimates, prioritization/categorization); advise on options, risks, costs/benefits, and impacts on end-users/processes/priorities.
- Collaborate with leadership, stakeholders, and process owners to cultivate technology solutions aligned to business/IT strategies; maintain strategic relationships.
- Plan and execute PDM Digital Strategy initiatives (e.g., SaaS web solutions, specialized applications, extending enterprise technologies); champion and prioritize initiatives; assist in application portfolio management.
- Direct internal and managed/contracted services staff to drive outcomes.
Essential Duties
- Build working knowledge of Biologics Clinical Manufacturing, Facilities & Engineering, and Quality Control.
- Communicate vision/roadmap/progress/risks/results; capture Voice of the Business and translate needs into system capability targets.
- Integrate business objectives into IT roadmaps; future-proof for scale/market/regulatory changes.
- Align business requirements to optimized processes (support business translation layer/DevOps); validate requirements to reduce rework; support change management/adoption.
- Track KPIs post-implementation; provide feedback loops for enhancements/roadmap updates.
Experience & Skills
- Strong communication, research, learning agility; collaboration and stakeholder management (verbal/written/negotiation); detail orientation and critical thinking.
- Experience with stakeholder management from middle management to executive level.
- Biologics Clinical Manufacturing platform exposure (e.g., MES/Electronic Batch Records, ERP Mfg, CMMS, Digital Process & Automation, Historian, IoT) and willingness to learn.
- Agile knowledge/tools (e.g., Jira, Asana).
- Programming (Python, R) and cloud (AWS) for analytics in life sciences desirable.
- Emerging tech awareness (e.g., GenAI, Digital Twin, PAT, AI/ML predictive analytics).
Basic Qualifications
- Bachelor’s degree and 5+ years relevant experience; or Master’s degree and 3+ years relevant experience.
- Degree in computer science/information sciences or related field (or equivalent experience).
Preferred Qualifications
- GxP and 21 CFR Part 11 knowledge; biotech/biopharma industry experience.
- Experience with implementations/integrations/cloud transformation and data security/compliance in scientific/healthcare settings.
People Leader Accountabilities
- Create inclusion, develop talent, and empower teams.
Compensation & Benefits (as stated)
- Salary range: $126,820.00–$164,120.00; may include discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Be a strategic technology partner to the PDM Biologics Clinical Manufacturing business capability; align technology direction with business goals; define relevant solutions and mature systems/services to drive business value.
- Lead ideation, planning, and development oversight for the capability; participate in short- and long-term business/IT strategic planning.
- Support business case development (resource estimates, prioritization/categorization); advise on options, risks, costs/benefits, and impacts on end-users/processes/priorities.
- Collaborate with leadership, stakeholders, and process owners to cultivate technology solutions aligned to business/IT strategies; maintain strategic relationships.
- Plan and execute PDM Digital Strategy initiatives (e.g., SaaS web solutions, specialized applications, extending enterprise technologies); champion and prioritize initiatives; assist in application portfolio management.
- Direct internal and managed/contracted services staff to drive outcomes.
Essential Duties
- Build working knowledge of Biologics Clinical Manufacturing, Facilities & Engineering, and Quality Control.
- Communicate vision/roadmap/progress/risks/results; capture Voice of the Business and translate needs into system capability targets.
- Integrate business objectives into IT roadmaps; future-proof for scale/market/regulatory changes.
- Align business requirements to optimized processes (support business translation layer/DevOps); validate requirements to reduce rework; support change management/adoption.
- Track KPIs post-implementation; provide feedback loops for enhancements/roadmap updates.
Experience & Skills
- Strong communication, research, learning agility; collaboration and stakeholder management (verbal/written/negotiation); detail orientation and critical thinking.
- Experience with stakeholder management from middle management to executive level.
- Biologics Clinical Manufacturing platform exposure (e.g., MES/Electronic Batch Records, ERP Mfg, CMMS, Digital Process & Automation, Historian, IoT) and willingness to learn.
- Agile knowledge/tools (e.g., Jira, Asana).
- Programming (Python, R) and cloud (AWS) for analytics in life sciences desirable.
- Emerging tech awareness (e.g., GenAI, Digital Twin, PAT, AI/ML predictive analytics).
Basic Qualifications
- Bachelor’s degree and 5+ years relevant experience; or Master’s degree and 3+ years relevant experience.
- Degree in computer science/information sciences or related field (or equivalent experience).
Preferred Qualifications
- GxP and 21 CFR Part 11 knowledge; biotech/biopharma industry experience.
- Experience with implementations/integrations/cloud transformation and data security/compliance in scientific/healthcare settings.
People Leader Accountabilities
- Create inclusion, develop talent, and empower teams.
Compensation & Benefits (as stated)
- Salary range: $126,820.00–$164,120.00; may include discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.