CMC Program Director – Biotech Project Leadership

Korsana Biosciences; Waltham (MA); On-site; USD 220,000 - 245,000; Full time

Benefits offered by this job

Bonus eligible

Equity compensation

Job summary

Korsana Biosciences in Waltham, MA seeks an Associate Director / Director, CMC Project Management to drive operational planning for CMC programs from pre-clinical IND enablement through clinical readiness.

This cross-functional, externally facing role involves coordinating with CDMOs/CROs and internal PMO, aligning with program milestones, managing budgets, and driving risk mitigation. Base salary range is $220,000–$245,000 with potential bonus and equity eligibility.

Qualifications

• Bachelor’s degree in scientific discipline or related field required; advanced degree preferred.
• 8–12+ years of biotech/pharma experience with at least 5 years in CMC project management or related roles.
• Experience with biologics and device development preferred.
• Experience working with CDMOs and external partners.
• Familiarity with regulatory requirements for CMC (IND-enabling, clinical supply) preferred.

Responsibilities

• Lead end-to-end project management of CMC activities across one or more development programs.
• Develop and maintain integrated CMC timelines and budget, ensuring alignment with program milestones.
• Drive planning, execution, and tracking of key CMC milestones, decision points, and deliverables.
• Partner with CMC leadership to prioritize resources and ensure execution against program goals.
• Lead internal CMC team meetings and coordinate with CDMOs/CROs, manage action items and risk log.
• Serve as primary interface between CMC and broader program teams (Research, Nonclinical, Clinical, Regulatory).
• Integrate CMC activities into overarching program plans, dashboards, and governance materials.
• Identify CMC risks and bottlenecks; communicate with leadership; coordinate with external partners.

Skills

Cross-functional coordination

Budget management

Timeline planning

Risk management

Stakeholder management

Executive communication

Education

Bachelor’s degree in science or related field

Advanced degree preferred

Tools

MS Project

Jira

PMO tools

Job description

Korsana Biosciences in Waltham, MA seeks an Associate Director / Director, CMC Project Management to drive operational planning for CMC programs from pre-clinical IND enablement through clinical readiness.

This cross-functional, externally facing role involves coordinating with CDMOs/CROs and internal PMO, aligning with program milestones, managing budgets, and driving risk mitigation. Base salary range is $220,000–$245,000 with potential bonus and equity eligibility.