Manager/Senior Manager, CMC Project Management

About this role

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a CMC Project Manager with experience in pharmaceutical development to be a key contributor within the CMC department to drive operational execution and ensure alignment with strategic objectives. The role will report into the Senior Director of CMC Project Management.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Job Responsibilities and Duties include, but are not limited to, the following:

• Manage day-to-day planning, coordination and execution of CMC project activities that may include early, late, and lifecycle stages, ensuring alignment within CMC project teams and cross-functionally

• Interface with and manage drug substance and drug product CDMOs involved with development activities related to formulations, manufacturing, analytical testing, packaging and labeling of investigational products

• Leverage established project management tools to track project execution, milestones, risks, and long-range planning to ensure appropriate communication to team members and management

• Lead internal team meetings and work collaboratively with CMC team leaders and other functional area team members to track critical operational aspects of the projects

• Participate as a key member of the CMC and internal project teams to develop and implement strategy for individual projects

• Contribute to the implementation and enhancement of project management tools, templates, dashboards, and operating mechanisms

• Participate in further developing processes, standards, and tools to enhance productivity and effectiveness toward meeting CMC team strategic goals

• Assist in preparation of CMC written documents for regulatory submissions (e.g. INDs, CTAs, NDA Module 3)

Requirements / Qualifications

• Bachelor’s/Master’s/PhD degree in a scientific/engineering discipline required

• At least 7 years of experience working within biopharmaceutical R&D or Technical Operations

• Strong understanding of end-to-end drug product development and CMC processes, and solid knowledge of GMP and regulatory…