Job#: 3014076

Job Description:

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.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.