Principal Project Manager – CGT

Position Overview:

We are seeking a highly experienced Project Manager to lead the execution of complex gene and cell therapy (GCT) development and manufacturing programs. This role is critical to ensure that cross-functional projects—including plasmid, mRNA, and viral vector platforms—are delivered on time, within scope, and in full compliance with regulatory and quality expectations. The successful candidate will have deep CGT domain knowledge, strong operational leadership, and a strategic mindset to manage internal systems and client-facing execution.

Key Responsibilities:

1. Strategic Project Leadership

• Lead end-to-end planning and execution of CGT-related programs (e.g., plasmid, mRNA, viral vector) across development and GMP manufacturing phases.
• Develop and maintain integrated project timelines, resource allocations, and deliverable tracking using tools such as Microsoft Project or Smartsheet.
• Actively drive internal and client-side alignment across CMC milestones.

1. Stakeholder Engagement & Cross-Functional Collaboration

• Coordinate across business development, finance, R&D, QA, QC, manufacturing, and regulatory affairs to ensure all project requirements are met.
• Maintain robust and proactive communication with internal and external stakeholders to ensure alignment, manage expectations, and report progress.
• Represent project status in executive reviews and client meetings with confidence and professionalism.

1. Operational Oversight & Continuous Improvement

• Monitor project budget, resource usage, and risk indicators; develop and implement mitigation strategies where needed.
• Lead issue resolution impacting scope, quality, or timelines.
• Optimize project management infrastructure, including internal trackers, documentation systems, and SOPs.

Qualifications:

• Bachelor’s degree in life sciences, engineering, or a related technical discipline; advanced degree preferred.
• Minimum 5 years of project management experience in the biopharmaceutical industry, with demonstrated leadership in GMP/CDMO environments.
• Deep understanding of CGT development lifecycle and regulatory requirements for IND/BLA.
• Proficiency in Gantt charting, project documentation systems, and PM collaboration tools (e.g., MS Project, SharePoint, MS Teams, Smartsheet).
• Ability to independently drive cross-functional teams and manage multiple concurrent projects.
• Strong leadership, communication, and interpersonal skills with a customer-first mindset.

Preferred:

• PMP (Project Management Professional) certification.
• Prior experience managing CMC projects involving plasmid, viral vector, or mRNA platforms.
• Direct experience in a CDMO setting with established track record of external client collaboration.

Key Competencies:

• Strategic thinking and decision-making under pressure
• Operational discipline and risk management mindset
• Excellent client management and negotiation skills
• Self-driven, positive, and resilient team player

#PB 

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