Associate Director / Director, CMC Project Management

About Us

Korsana Biosciences is a private biopharmaceutical company advancing a pipeline of potential best-in-class therapies for neurodegenerative diseases. In partnership with Paragon Therapeutics, we have developed Therapeutic Targeting (THETA™), a novel blood-brain barrier-penetrant shuttle platform designed to enable dramatically higher drug concentration inside the brain and overcome the limitations of earlier shuttle technologies. Our lead program is KRSA-028, an investigational, shuttled antibody targeting amyloid beta designed to be a best-in-class treatment for Alzheimer’s disease. Our mission is to advance precision-engineered therapies, designed to address some of the biggest unmet needs in medicine.

Position Overview

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.

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.
• Carefully 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.

Education & Experience

• 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.
• Experience with biologics and device development preferred.
• Demonstrated experience supporting CMC activities across development stages (preclinical through clinical).
• Experience working with CDMOs and external manufacturing/analytical partners.
• Familiarity with regulatory requirements for CMC (e.g., IND-enabling, clinical supply) preferred.

Skills & Attributes

• 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.
• Prowed knowledge of anticipating risks, solving problems, and driving execution in a fast-paced environment.
• A high attention to detail while maintaining a strategic, big-picture perspective.
• A collaborative, proactive, and hands-on mindset with a focus on delivering results.
• Ability to balance structure with flexibility as programs and priorities evolve.

Pay

The anticipated base salary range for this position is $220,000 - $245,000. This role may also be eligible for a target annual bonus and equity-based compensation, as well as participation in the company’s benefit programs. Actual compensation will depend on several factors, which may include, but are not limited to relevant years of experience, educational background, and geography.

Benefits

Korsana Biosciences offers a comprehensive benefits package that includes health insurance, retirement plans, paid time off, and more. Details can be found on our website or by contacting HR directly.

Equal Opportunity Employer

We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.