Associate Director / Director, CMC Project Management

Korsana Biosciences•Waltham, MA

8h•$220,000 - $245,000

About The Position

The Associate Director / Director, CMC Project Management will play a critical role in driving the operational planning including timelines, deliverables and budget, integration and execution of Korsana’s CMC development programs across the portfolio. The position serves as a vital role within CMC, driving cross-functional alignment, integrated planning and execution from pre-clinical IND enablement through commercial readiness. This is a highly cross-functional and externally facing role, requiring close coordination with internal stakeholders and external CDMOs, CROs, and vendors to ensure seamless execution of CMC activities from early development through clinical stages. This individual will report to the Head of Program Management but will be embedded within the CMC organization, working in close partnership with CMC leadership and matrixed teams, while remaining integrated within the Program Management Organization (PMO).

Requirements

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 of experience in CMC project management, technical operations, or a related role.
Demonstrated experience supporting CMC activities across development stages (preclinical through clinical).
Experience working with CDMOs and external manufacturing/analytical partners.

Nice To Haves

Experience with biologics and device development preferred
Familiarity with regulatory requirements for CMC (e.g., IND-enabling, clinical supply) preferred
Strong understanding of CMC development processes, timelines, budget, and interdependencies.
Excellent organizational and project management skills, with the ability to manage complex, cross-functional activities.
Strong communication and stakeholder management skills; able to influence without authority in a matrixed environment.
Proven ability to anticipate risks, solve problems, and drive execution in a fast-paced environment.
High attention to detail while maintaining a strategic, big-picture perspective.
Collaborative, proactive, and hands-on mindset with a focus on delivering results.
Ability to balance structure with flexibility as programs and priorities evolve

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 closely 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.