Associate Director / Director, CMC Project Management

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

Associate Director / Director, CMC Project Management

Korsana Biosciences, Inc. Waltham, Massachusetts, United States

About this position

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. For more information, please visit www.korsana.com

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. 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).

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.

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.
• 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 hand‑on mindset with a focus on delivering results.
• Ability to balance structure with flexibility as programs and priorities evolve

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.

Korsana Biosciences is the seventh groundbreaking company launched by Paragon Therapeutics, a premier biotech incubator founded by Fairmount Funds in 2021, known for its expertise in discovering and developing cutting‑edge therapeutic assets in‑house.

Korsana Biosciences is an 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.