Job Description

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)

Day to Day:

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 teams 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

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