Manager, Analytical Development

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 Manager, Analytical Development to manage and coordinate analytical activities on multiple early and/or late phase clinical development programs. The ideal candidate will be a team player comfortable working on a small team in a fast-paced environment and with contract manufacturing and development organizations. Excellent time management skills and communication will be key in succeeding in this role. This position requires an extensive hands-on laboratory experience using a broad array of analytical instrumentation.  

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:

• Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early phase drug substance (40%) and drug product (60%) small molecule solid oral formulation programs

• Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)

• Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages

• Assist in authoring CMC sections for regulatory submissions

• Manage drug substance and drug product stability programs (QC and technical review of stability data packages that includes raw data, and stability data trend analysis)

• Assist in the development of standard operating procedures

• Manage reference materials and reference standards inventory and (re)qualification testing

Requirements / Qualifications

• Bachelor’s degree in Analytical Chemistry or Chemistry or related field with 5+ years' experience or MS/PhD with 3+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development

• Knowledge of drug product solid oral dose formulations

• Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size

• Functional understanding of small molecule analytical development and associated regulatory and quality requirements

• Hands on experience with LC-MS/MS and GC-MS is a plus

• 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

• Demonstrated experience in managing outsourced analytical activities

• Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product

• Experience working on commercial stage products highly valued

• Excellent verbal and written communication skills

• Excellent problem solving and interpersonal skills

• Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities.

• Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently

• Flexibility to accommodate multiple time zones as needed

• Willingness to travel periodically as needed

Salary & Benefits

The anticipated salary range for this role is $120,000 - $135,000. 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.