Senior PM (Biotech - Phase III)

Senior PM (Biotech - Phase III)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 clientContract/Perm & duration: 12-month contract (potential for extension)Location: Fully RemotePerforming PM activities to ensure CSI (Cell Suspension for Injection) Hub and Clinical Supply network readiness and on-going supply management for a Phase III clinical trial. Project Management responsibilities for CSI Strategy, Operations, and Logistics Workstream. Responsibilities: Deliver on above scope of work, within mutually agreed upon calendar and timelinesAcknowledge BlueRock 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 budgetCreate integrated project plans; scope, work, resources, scheduling, etc.Facilitate the definition of project scope, goals and deliverables were applicable Develop and maintain integrated workstream timeline Drive risk management process, i.e., identification through mitigationFacilitate lessons learned assessmentCoordinate meetings and meeting logistics, keeping clear minutes, actions, decisions, and tracking associated follow-througPartner with key stakeholders and leads to successfully achieve program and project objectivesMonitor execution and quality to BlueRock standardsIdentify and resolve issues, offer viable solutions and opportunities as they ariseReport on program and project progressImplement appropriate project change controlMonitor resources to make sure schedule is on trackWork 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 LeadershipStrong CMC/TT/Clinical Supply PM presence, driving the team and workstreams, planning and action trackingPartner with CSI Workstream Leads, Bemda CMC Lead, Bemda CMC PMs, Manufacturing Management, Operations Manager, Clinical Supply Integrated Planning TeaDrive Workstream PM structure: identify scope, confirm deliverables and work and create/confirm timelines, conduct risk assessments, follow up risk mitigation planning and escalate risks and issues appropriatelyFacilitate CSI Bluerock 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.Key Qualifications: 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 and clinical supply planning.Proficiency with project management software (e.g., MS Project, Smartsheet) and collaboration tools.Ability to monitor resource allocation and ensure adherence to timelines and budgets.Strong problem-solving and decision-making abilities.Excellent written and verbal communication skills.Ability to adapt to changing business needs and manage ambiguity. Apply tot his job Apply To this Job