Director, CMC Project Management

Jobtailor; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Jobtailor is seeking a seasoned CMC Program Manager to lead end-to-end CMC projects for biologics in a lean, cross-functional setting. You will own integrated plans, ensure alignment across process development, manufacturing, quality, regulatory, and finance, and partner with the CMC Lead to drive decisive execution.

The role emphasizes AI-enabled tools, risk management, and executive-level updates, with a strong owner mentality and experience coordinating with CDMOs and external vendors.

Qualifications

• Bachelor's or Master’s degree in science or engineering required.
• PMP certification strongly preferred.
• 10+ years of program management experience in CMC for biologics.
• Experience with CDMOs and external partners.
• Familiarity with AI/advanced analytics in PM workflows.

Responsibilities

• Lead end-to-end CMC program execution across development stages.
• Coordinate cross-functional teams (process development, manufacturing, QA, regulatory, supply chain).
• Own integrated CMC project plans, timelines, and milestones.
• Lead core CMC team meetings and drive accountability.
• Partner with CMC Lead in joint leadership model.

Skills

CMC Program Management

Biologics Development

PMP Certification

Stakeholder Management

AI Tools Application

Education

MS or BS in a scientific or engineering discipline

Tools

Project Management Platforms

AI-Enabled Tools

Data Analytics Tools

Job description

• Support end-to-end CMC project execution for biologics
• Integrate strategy and execution across process development, manufacturing, supply chain, quality, and regulatory functions
• Own and drive integrated CMC project plans, timelines, and milestones across all development stages
• Lead core CMC team meetings and ensure alignment, accountability, and follow-through actions
• Partner closely with the CMC Lead in a joint leadership model for each program
• Drive execution of agreed-upon strategy
• Manage cross-functional dependencies
• Ensure decisions are implemented efficiently
• Manage internal and external document reviews and approvals, including liaising with Finance on budgets
• Monitor external partner performance and elevate risks as needed
• Continuously assess program progress and proactively manage risks, gaps, and contingencies
• Act as a primary program interface with CDMOs and major external vendors
• Drive alignment on timelines, deliverables, and issue resolution
• Integrate activities across Technical Operations, Regulatory, Finance, and Legal
• Leverage AI-enabled tools and scalable program management practices to strengthen planning, risk management, visibility, and execution
• Prepare concise, data-driven updates for executive leadership in partnership with the CMC Lead
• Communicate CMC project status, risks, and mitigation plans

Requirements

• MS or BS in a scientific or engineering discipline required
• PMP certification is strongly preferred
• Minimum 10 years of relevant experience, including 6 years managing CMC programs for biologics
• Solid understanding of biologics CMC, including development, manufacturing, and regulatory requirements
• Experience working with CDMOs and external partners
• Experience applying AI tools or advanced analytics to program management workflows
• Familiarity with project management platforms and data visualization tools
• Demonstrated success operating in a lean, operationally efficient environment
• Ability to engage deeply with cross-functional teams and effectively partner with CMC Lead
• High ownership, execution leadership, and ability to drive results in a lean environment with a lean, but evolving structure
• Agile and resourceful, comfortable navigating ambiguity and shifting priorities
• Strong stakeholder management and issue resolution skills
• Ability to partner effectively with technical leadership while maintaining execution ownership
• Strong technical fluency with the ability to translate CMC discussions into clear plans, actions, timelines, and risks
• Clear, concise communicator with strong executive presence

Core Competencies

Demonstrates expertise in managing CMC programs for biologics, integrating cross-functional strategies, and driving execution in a lean environment. Proficient in stakeholder management, risk assessment, and utilizing AI tools for program management.

Highest-signal resume keywords

• CMC Program Management
• Biologics Development
• PMP Certification
• Stakeholder Management
• AI Tools Application

Hard Skills

• Biologics CMC
• Program Management
• Risk Management
• Data Visualization
• Regulatory Requirements
• Manufacturing Processes
• Project Management
• Cross-Functional Collaboration
• Budget Management
• Lean Operations

Soft Skills

• Clear Communication
• Execution Leadership
• Problem Solving
• Adaptability
• Team Engagement

Certifications & Qualifications

• PMP Certification

Industry Keywords

• CDMO
• Technical Operations
• Regulatory Affairs
• Supply Chain Management
• Quality Assurance

Tools & Technologies

• Project Management Platforms
• AI-Enabled Tools
• Data Analytics Tools