CMC Program Director - Biologics, AI-Driven Execution

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

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.