Senior Project Manager, CMC

Responsibilities (Position responsibilities may include, but are not limited to):

• Develop and maintain integrated CMC project plans, timelines, and risk management strategies aligned with corporate objectives and program goals. 
• Facilitate CMC sub-team meetings and cross-functional meetings, ensuring clear communication of goals, progress, risks, and mitigation strategies. 
• Track deliverables and proactively identify & address potential bottlenecks or challenges. 
• Support the preparation of CMC-related regulatory submissions, including INDs, BLAs, and briefing documents, by coordinating timelines and deliverables. 
• Partner with external CDMOs, CROs, and manage alliances with key suppliers to ensure seamless execution of outsourced activities and maintain alignment with project timelines.  Implement and improve project management tools and best practices to enhance team efficiency and performance.
• Develop project dashboards and reports to communicate project status to leadership and key stakeholders. 
• Ensure alignment between CMC and broader program teams to support overall development strategy and corporate milestones. 
• Support budget planning and resource allocation in collaboration with finance and functional leaders.

Qualifications (Required):

• Bachelor’s degree in a life science, engineering, technology, business, or related field; an advanced degree (MS, PhD, or MBA) is preferred. 
• 8+ years of experience in the biotechnology or pharmaceutical industry, with at least 5 years of direct project and portfolio management in a science-based organization, with a strong CMC focus. 
• Proven experience managing cross-functional teams and external partners (e.g., CDMOs) in a fast-paced environment to deliver against CMC milestones, ideally to enable IND filings, early clinical, and late-stage clinical activities to drive program expansion from Phase 1 to pivotal development for cell therapies in oncology. 
• Strong understanding of CMC development & operations for cell and gene therapy or biologics, including: ○ Process development and technology transfer ○ Good Manufacturing Practices ○ Contamination management & remediation ○ Current regulatory and quality considerations 
• Excellent organizational, problem-solving and communication skills with the ability to influence and drive decision-making. 
• Experience leading Operational Excellence, process mapping and optimization. 
• Proficiency in project management best practices and tools (e.g., Microsoft Project, SmartSheet, or equivalent) 
• Familiarity with Agile or phase-gate project management methodologies. 
• Strong analytical & problem-solving skills, with the ability to synthesize complex information into actionable insights.
• Exceptional interpersonal skills, including the ability to motivate teams, maintain positive working relationships with collaborators, influence without authority, and effectively resolve conflicts. 
• Proven ability to manage multiple projects, take initiative, and work cross-functionally in a dynamic environment. 
• Excellent written and verbal communication skills, with the ability to convey technical and strategic information (including the core elements of engineered T cell therapies) effectively to scientific and business audiences. 
• Proven ability to identify risks proactively, prioritize tasks, and drive issue resolution.
• Proven success in goal setting, prioritization, and time management. 
• Results-oriented, detail-oriented, and self-motivated, with the ability to work independently with minimal supervision. 
• Thrives in a fast-paced, dynamic environment, adapting effectively to evolving priorities and ambitious timelines.

Qualifications (Preferred):

• PMP or equivalent project management certification is a plus. 
• Experience in both early and late-stage clinical trials is a plus. 
• Broader nonclinical and clinical development experience is highly advantageous.
• Familiarity with FDA regulatory processes and clinical trial management. 
• Direct experience working on gene or cell therapy development programs, with recent cell therapy experience for oncology being particularly desirable.