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Product Operational Specialist

Product Operational Specialist

Insight GlobalHolly Springs, NC, US
1 day ago
Job type
  • Full-time
Job description

Job Description :

A large pharmaceutical client is looking for 2 Sr. Operational Readiness Project Managers to join their team in Raleigh-Durham. In this role you will be responsible for overseeing a successful turnover of both upstream and downstream equipment to ensure manufacturing is ready for operations. This role will be based onsite 5x per week.

  • Lead project scope definition for Operational Readiness workstreams such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control, among others
  • Develop execution strategies, detailed schedules, and risk registers
  • Integrate and actively facilitate workstreams day-to-day execution
  • Facilitate team meetings and execution forums
  • Represent workstreams in appropriate governance forums
  • Liaise with other project PMs to ensure effective project delivery
  • Closely manage schedule performance and provide updates to management
  • Ensure internal alignment of operational readiness schedules, as well as externally with construction and commissioning / qualification workstreams
  • Provide strategic guidance on overall project delivery to de-risk and optimize execution
  • Resolve workstream issues arising throughout the project, manage risk register, and escalate when appropriate to keep objectives and deliverables on track
  • Lead and facilitate cross-functional workshops required to ensure project alignment, solve project challenges, identify gaps, and advance site strategy
  • In this role you will not manage people, nor budgets

Must Haves :

  • 10+ years of Project Management experience
  • Experience in Biologics Drug Substance manufacturing operations (ideally Downstream and / or Upstream operations)
  • Understanding of the change control process
  • Understanding of manufacturing support systems (ie MES, PI, DeltaV, etc)
  • Understanding of operations support systems (ie Trackwise, LIMS, Maximo, etc)
  • Understanding of supporting functions within a biopharmacautical operation (ie Quality Control, Process Development, Engineering, etc)
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    Product Specialist • Holly Springs, NC, US

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