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 experienceExperience in Biologics Drug Substance manufacturing operations (ideally Downstream and / or Upstream operations)Understanding of the change control processUnderstanding 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)