Sr. Manager, CMC Project Management

The CMC Project Manager is responsible for driving cross‑functional execution of Commercial CMC programs for approved cell and gene therapy products. This role partners closely with CMC functional leaders and teams to ensure disciplined planning, risk management, and delivery of post‑approval commitments that support uninterrupted commercial supply.

A primary focus of the role will be leading a CMC sub‑team, including coordination with an external partners, to deliver a critical commercial milestones. This position operates in a highly matrixed environment and requires strong project leadership, clear communication, and the ability to manage complex interdependencies across CMC functions.

This role is a full time hybrid position (3 days a week in the office) located in our Somerville, Massachusetts office.

RESPONSIBILITIES

• Lead Commercial CMC teams and drive execution of CMC activities aligned with program, regulatory, and supply objectives
• Develop, maintain, and actively manage integrated CMC project plans, including timelines, dependencies, critical path activities, and decision points
• Establish and maintain a CMC risk registry; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays
• Lead cross‑functional coordination across Manufacturing, Quality, Analytical Development, Regulatory CMC, Supply Chain, and external partners to resolve complex CMC issues
• Manage CMC execution in collaboration with key external partners, ensuring accountability to scope, timeline, and deliverables for key commercial milestones
• Prepare and deliver concise, data‑driven updates to senior leadership and governance forums on CMC status, risks, and execution options
• Co‑lead CMC team meetings and governance forums, applying strong meeting management practices to enable timely decision‑making and follow‑through
• Promote a culture of ownership, accountability, and continuous improvement across CMC project teams

QUALIFICATIONS

• Bachelor’s, Master’s, or Ph.D. in life sciences or a related discipline, or equivalent industry experience
• Minimum of 6 years of biopharmaceutical industry experience; experience supporting late‑stage or commercial programs strongly preferred
• At least 2 years of project management experience or demonstrated success leading cross‑functional teams in a fast‑paced biotech or pharmaceutical environment
• Proven ability to manage complex, cross‑functional programs, identify and mitigate risk, and drive execution in a matrixed organization
• Strong working knowledge of CMC development, manufacturing, and quality concepts; cell and gene therapy experience is a strong plus
• Proficiency with project management and collaboration tools, including Microsoft Project, PowerPoint, Excel, and OneNote
• Strong organizational skills with the ability to manage multiple priorities and shifting timelines
• Demonstrated ability to translate complex technical plans into clear, actionable communication for technical and non‑technical stakeholders