Senior Project Manager, CMC

Position Overview

We are seeking an experienced Project Management professional with expertise in Chemistry, Manufacturing and Control (CMC) to support our dynamic team in advancing our pipeline of innovative targeted cancer therapies. This position, reporting to the head of Program Management, will play a critical role in overseeing the development, manufacturing, and quality control processes of our pharmaceutical products. You will coordinate functions within CMC and develop and drive timelines to meet the needs of the product development teams for both early and late-stage products. This role requires a blend of technical expertise in chemistry and manufacturing processes, project management expertise, and strong communication skills. 

Responsibilities

Strategic Execution: 

• Support and execute the strategic vision for CMC programs, aligning with organizational goals and product requirements, translating strategy into integrated execution plans, key milestones, and decision points.
• Own integrated CMC timelines, governance reporting, and risk/issue management; escalate scope, resourcing, strategic tradeoffs, and budget exceptions to leadership for decision.
• Lead cross-functional execution of the CMC plan to ensure successful delivery of CMC initiatives; facilitate alignment, clarify accountability, and escalate tradeoffs/risks to leadership as needed.

Project Management: 

• Develop, maintain, and drive integrated CMC timelines for manufacturing to meet the needs of the product team, including critical path identification, dependencies, and scenario planning.
• Coordinate activities within CMC to ensure efficient and cost-effective production of candidate molecules; drive readiness for key deliverables (plans, protocols, batch documentation readiness, method readiness) as appropriate to phase.
• Coordinate production of commercial batches as needed; in partnership with TechOps, Quality, and external manufacturers.
• Leverage strong project and facilitation skills to optimize team meetings and decision making, including agendas, action/owner tracking, decision logs, and follow-through.

Cross-Functional Collaboration: 

• Foster strong collaboration with R&D, quality assurance, regulatory affairs, development and other relevant departments to ensure alignment and integration of CMC activities.
• Serve as a liaison between internal stakeholders and external partners, such as contract manufacturing organizations (CDMOs) and vendors, ensuring clear communication and alignment on scope, timelines, deliverables, and change control/escalations.

Project Reporting: 

• Ensure that senior management/development teams are informed of important program timelines, milestones and risks, and decision points; provide clear escalation paths for issues requiring leadership input.
• Lead preparation of program/platform dashboards and presentations, including integrated timeline views and RAID summaries (Risks, Assumptions, Issues, Dependencies).

Budgeting:  

• Own budget tracking and forecasting within CMC for assigned programs; prepare budget updates and variance analyses.
• Manage project budgets to target by monitoring spend vs forecast, identifying variances early, and coordinating mitigation plans with functional leads.

Qualifications

• Bachelor’s degree in a technical field such as chemistry, chemical engineering or pharmaceutical sciences required; advanced degree preferred.
• Specific project management training desirable.
• A minimum of 4 years of Project Management experience in pharmaceutical development and manufacturing, with a focus on CMC.

Knowledge and Skills

• Proven track record of successfully supporting CMC programs from development through commercialization, including vendor oversight, integrated plans, and governance reporting.
• Strong communication skills, with the ability to influence and collaborate effectively across diverse teams without direct supervisory authority.
• Demonstrated ability to manage multiple projects simultaneously and prioritize effectively in a fast-paced environment.
• Proficiency in project management tools and software (e.g., MS Project, SmartSheet, Trello).
• Experience in the biotech, pharmaceutical, or healthcare industry is a plus.
• High proficiency in MS Office Suite (Word, Excel, PowerPoint).