Senior Manager, CMC Project Management

Responsibilities

• Lead cross-functional project teams or sub-teams to manage the planning and execution of program activities in alignment with corporate goals.
• Develop, maintain, and actively manage integrated project plans including timelines, dependencies, critical path activities, decision points, and budget considerations.
• Establish and maintain risk registries; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays.
• Facilitate decision-making processes by working with cross-functional teams to develop proposals, analyses, and recommendations for senior management review as part of the governance process.
• Serve as the primary project management point of contact for CMC and, as needed, Clinical Development activities on assigned programs.
• Ensure comprehensive knowledge of scope, deliverables, timelines, status, and key risks while coordinating cross-functional dependencies across CMC and Clinical workstreams to maintain alignment with program strategy.
• Contribute to planning, organization, and preparation of regulatory filings (e.g., IND, BLA, CMC supplements) in partnership with Regulatory and relevant functional teams.
• Prepare and deliver concise, data-driven program and project status updates, dashboards, and reports to senior leadership and governance forums.
• Manage project team meeting operations including agenda planning, scheduling, minutes preparation, and follow-up on action items and decisions.
• Ensure project activities and decisions are clearly communicated, documented, and archived in accordance with team standards and tools.
• Foster strong relationships with team members, functional line managers, and external partners to facilitate timely resolution of issues, risks, and opportunities.
• Support program-level budget management activities, including tracking expenditures and financial forecasting for assigned programs.
• Participate as a member of the Portfolio & Program Management Team to continually improve project management processes, tools, and governance frameworks.

Requirements & Experience

• Bachelor’s Degree in life sciences or related field required (or relevant experience) with at least 7 years of project management experience in similar role in the biotechnology industry (with meaningful exposure to CMC or Operations Technology functions).
• At least 3 years of direct project management experience leading cross-functional teams in a matrixed environment; formal project management certification (e.g., PMP) is a plus.
• Working knowledge of CMC development concepts such as process development, analytical development, manufacturing, quality systems, supply chain, and regulatory CMC requirements.
• Familiarity with Clinical Development processes and the drug development lifecycle from Pre-IND through BLA is preferred.
• Cell therapy experience is strongly preferred; experience with biologics or complex modalities is highly desirable.
• Demonstrated ability to manage complex, cross-functional programs, identify and mitigate risks, and drive execution in a fast-paced, dynamic environment.
• Proficiency with project management and collaboration tools (e.g., Smartsheet, Microsoft Project, SharePoint, Microsoft Office Suite).
• Knowledge of GMP/GxP-regulated environments and quality management systems preferred.
• Experience supporting late-stage development or commercial-stage programs preferred.
• Prior experience in a start-up or growth-stage biotechnology organization preferred.
• Familiarity with cell therapy manufacturing processes and supply chain considerations preferred.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.