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 othersDevelop execution strategies, detailed schedules, and risk registersIntegrate and actively facilitate workstreams day-to-day executionFacilitate teams meetings and execution forumsRepresent workstreams in appropriate governance forumsLiaise with other project PMs to ensure effective project deliveryClosely manage schedule performance and provide updates to managementEnsure internal alignment of operational readiness schedules, as well as externally with construction and commissioning / qualification workstreamsProvide strategic guidance on overall project delivery to de-risk and optimize executionResolve workstream issues arising throughout the project, manage risk register, and escalate when appropriate to keep objectives and deliverables on trackLead and facilitate cross-functional workshops required to ensure project alignment, solve project challenges, identify gaps, and advance site strategy