CMC Program Director — Biotech Development

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

Job summary

Korsana Biosciences, Inc. in Waltham, MA is seeking an Associate Director / Director of CMC Project Management to lead end-to-end CMC activities across development programs and ensure integrated planning from preclinical IND enablement through commercial readiness.

The role collaborates with CDMOs/CROs and internal teams, balancing timelines, budget, and deliverables while driving risk management and governance.

Qualifications

• Bachelor’s degree in scientific discipline or related field required; advanced degree preferred.
• 8‑12+ years of relevant experience in biotech/pharmaceutical industry, with at least 5 years in CMC project management, technical operations, or related role.

Responsibilities

• Lead end-to-end project management of CMC activities across one or more development programs.
• Develop and maintain integrated CMC timelines, budget, ensuring alignment with overall program milestones and critical path activities.
• Drive planning, execution, and tracking of key CMC milestones, decision points, and deliverables (e.g., drug substance, drug product, analytical/quality control, device, clinical supply chain, GMP quality, and regulatory-CMC).
• Partner with CMC leadership to ensure clear prioritization, resource alignment, and execution against program goals.
• Lead internal CMC team meetings and coordinate meetings with CDMOs/CROs, issue meeting agenda and minutes, maintain and follow up on action item log and project risk register.
• Serve as the primary interface between CMC and the broader program team (Research, Nonclinical, Clinical, Regulatory).
• Integrate CMC activities into overarching program plans, dashboards, and governance materials.
• Proactively identify CMC risks, dependencies, and potential bottlenecks across development stages and ensure clear communication to program teams and senior leadership. Coordinate and track activities across CDMOs, CROs, and other external CMC partners.
• Ensure alignment of external timelines and deliverables with internal program plans.
• Partner with CMC and functional leads to monitor vendor performance, identify risks, and drive issue resolution.
• Champion adoption of PMO tools, templates, and best practices within the CMC function.
• Contribute to the development of scalable PMO processes to support organizational growth.

Skills

CMC development

Project management

Cross-functional coordination

Stakeholder management

Communication

Risk management

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

Korsana Biosciences, Inc. in Waltham, MA is seeking an Associate Director / Director of CMC Project Management to lead end-to-end CMC activities across development programs and ensure integrated planning from preclinical IND enablement through commercial readiness.

The role collaborates with CDMOs/CROs and internal teams, balancing timelines, budget, and deliverables while driving risk management and governance.