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Project Manager

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Job Title: Project Manager

Location: Holly Springs, NC

Duration: 12 Months contract to hire

Schedule: Business hours (Hybrid) minimum 3 days onsite

Job Description:

  • You will be responsible for managing Operational Readiness activities during site start-up. You will lead the planning, coordination, and tracking of operations cross-functional workstreams in alignment with Construction and Commissioning & Qualification workstreams. Your duties will include developing readiness plans and detailed schedules, facilitating workshops, facilitating activity execution, owning workstream forums, managing risks, resolving challenges, project communications, performance tracking, and documenting lessons learned.
  • We are looking for a professional with strong project management and communication skills, proficiency in project management software, experience with medium to large-scale projects, and knowledge of biotech DS manufacturing processes. The ideal candidate will also have excellent analytical skills, an understanding of operational excellence, and the ability to work under tight deadlines and manage strategic changes.

Key Responsibilities Include:

  • Develop readiness plans, schedules, and risk registers for multiple workstreams (Manufacturing, Engineering, Process Development, Supply Chain, Quality Control)
  • Map project deliverables, key milestones, and critical dates
  • Create detailed schedules to ensure clear visibility of critical paths
  • Facilitate cross-functional workshops to align activities, resolve challenges, and identify gaps
  • Monitor schedule and facilitate execution forums for efficient workstream execution
  • Implement communication strategies with standardized tools for proactive project monitoring and reporting
  • Provide updates to project sponsors and senior leaders
  • Resolve issues, manage risks, and escalate as needed to maintain project objectives and deliverables
  • Collaborate with other project managers for cross-functional alignment, including construction and commissioning/qualification workstreams
  • Provide strategic guidance on project delivery to de-risk and optimize execution

Top 3 Must Have skills:

  • Thorough understanding of project management processes, methodologies, and best practices
  • Knowledgeable in pharma/biotech processes and support functions (ideally in Drug Substance manufacturing
  • Proficient in building strong relationships and partnerships at all organizational levels
  • Nice to have: experience coordinating with multiple teams. Experience presenting to senior leadership.

Basic Qualifications:

Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience