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 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 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 timelines
- Acknowledge 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 budget
- Create 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 mitigation
- Facilitate lessons learned assessment
- Coordinate meetings and meeting logistics, keeping clear minutes, actions, decisions, and tracking associated follow-throug
- Partner with key stakeholders and leads to successfully achieve program and project objectives
- Monitor execution and quality to BlueRock 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 workstreams, planning and action tracking
- Partner with CSI Workstream Leads, Bemda CMC Lead, Bemda CMC PMs, Manufacturing Management, Operations Manager, Clinical Supply Integrated Planning Tea
- Drive 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 appropriately
- Facilitate 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.
