Manager/Senior Manager, CMC Project Management at Axsome Therapeutics

New York, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

155000.0

Posted On

18 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMC project management, Drug product development, CDMO management, GMP, Regulatory submissions, Cross-functional leadership, Risk management, Strategic planning, Project execution, Analytical testing, Formulation development, Manufacturing, IND documentation, NDA documentation, ICH guidelines, Problem-solving

Industry

Biotechnology Research

Description

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 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 Experience, Knowledge and Skills 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 Salary and Benefits: The anticipated salary range for this role is $125,000 - $155,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Responsibilities

Manage the day-to-day planning, coordination, and execution of CMC project activities while ensuring alignment with strategic objectives. Interface with CDMOs and lead cross-functional teams to track critical operational aspects and regulatory submission documentation.