Senior PM; Biotech - Phase III

Senior PM (Biotech - Phase III)

Job#: 3014076

Apex Systems is a large staffing and consulting firm and we are looking for a Senior Project Manager with a background in the Biotech or Pharma industries, experience with leading the collaboration for Phase III programs, knowledge of collaborating across manufacturing, supply chain, QA/QC, etc., and strong knowledge of GMP/GDP compliance to place at our Biopharma client.

Client:
Innovative Biopharma client

Contract/Perm & duration: 12-month contract (potential for extension)

Location:

Fully Remote

Performing PM activities to ensure CSI (Cell Suspension for Injection) Hub and Clinical Supply network readiness and ongoing supply management for a Phase III clinical trial. Project Management responsibilities for CSI Strategy, Operations, and Logistics Workstream.

• Deliver on above scope of work, within mutually agreed upon calendar and timelines
• Acknowledge Blue Rock may need to adjust scope to accommodate business needs, if necessary, work towards updated and mutually agreed upon path forward.
• Support CSI Teams by:
  • Provide strong team leadership and drive to ensure projects are executed within scope, on‑time and within budget
  • Create integrated project plans; scope, work, resources, scheduling, etc.
  • Facilitate the definition of project scope, goals and deliverables where applicable
  • Develop and maintain integrated workstream timeline
  • Drive risk management process, i.e., identification through mitigation
  • Facilitate lessons learned assessment
  • Coordinate meetings and meeting logistics, keeping clear minutes, actions, decisions, and tracking associated follow‑through
  • Partner with key stakeholders and leads to successfully achieve program and project objectives
  • Monitor execution and quality to Blue Rock standards
  • Identify and resolve issues, offer viable solutions and opportunities as they arise
  • Report on program and project progress
  • Implement appropriate project change control
  • Monitor resources to make sure schedule is on track
  • Work with internal and external stakeholders to manage deliverables, e.g., CMO’s, Supply Chain, etc.
  • Communicate status to Tech Ops PMO, Program and Tech Ops Leadership
• Strong CMC/TT/Clinical Supply PM presence, driving the team and work streams, planning and action tracking
• Partner with CSI Workstream Leads, Bemda CMC Lead, Bemda CMC PMs, Manufacturing Management, Operations Manager, Clinical Supply Integrated Planning Team
• Drive Workstream PM structure: identify scope, confirm deliverables and work and create/confirm timelines, conduct risk assessments, follow up risk mitigation planning and elevate risks and issues appropriately
• Facilitate CSI Blue Rock Internal meetings: drive agenda, material, notes, and action items
• Partner with CMC PMs to support structure and oversight of activities
• Facilitate CSI External collaboration and communications with CSI Hub partner PMs
• Lead supporting sub-Workstream PMs for Mfg Execution, Clinical Supply, etc.
• Partner with Workstream Leads;
  Tech Transfer (TT) Leads, MFG, QC, QA, SC and Reg.

• Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s or PMP certification preferred).
• Strong understanding of biotech/pharmaceutical industry processes, including CMC (Chemistry, Manufacturing, and Controls), Tech Transfer, and Clinical Supply Chain.
• 8+ years of proven experience managing complex, cross-functional projects within biotech or pharmaceutical environments.
• Skilled in creating and maintaining integrated project plans (scope, resources, timelines).
• Proficiency in risk management, including identification, mitigation planning, and escalation.
• Experience with change control processes and lessons‑learned assessments.
• Demonstrated ability to lead and motivate cross-functional teams.
• Excellent stakeholder management skills, including internal teams and external partners (e.g., CMOs, supply chain vendors).
• Strong meeting facilitation skills: agenda setting, documentation, and action tracking.
• Familiarity with manufacturing operations, quality control (QC), quality assurance (QA), regulatory requirements, and supply chain processes.
• Understanding of tech transfer principles…