Manager/Senior Manager, CMC Project Management

Axsome Therapeutics•New York, NY

5h•$125,000 - $155,000•Onsite

About The Position

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.

Requirements

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 requirements
Hands-on experience in one or more drug product development areas (e.g. formulations, manufacturing, analytical)
Demonstrated success in leading cross-functional teams in a matrixed environment, proficiency with project planning and reporting, and risk management
Excellent written and verbal communication and interpersonal skills with good problem-solving ability; experienced in presenting to senior stakeholders
Willingness to travel periodically as needed
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Nice To Haves

Certified project management training (PMP) a plus, preferred but not required
Experience with project management software or other presentation/reporting tools preferred
Solid understanding of FDA regulatory guidance, ICH guidelines and requirements of NDA and IND documentation
Prior experience interfacing with and managing drug substance and drug product CDMOs preferred
Technical experience with solid oral dosage form development preferred but not required
Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities

Responsibilities

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)