Associate Director/Director, Technical Operations - Drug Substance (Small Molecules)

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 an Associate Director/Director, Technical Operations – Drug Substance (Small Molecules) to provide technical leadership across the development and commercial lifecycle of small‑molecule drug substance programs. This role is responsible for supporting and overseeing drug substance manufacturing activities, including technology transfer, process validation, continued process verification (CPV), and post‑approval process changes at internal and external manufacturing sites. The successful candidate will serve as a key technical leader within CMC, partnering closely with external CDMOs and internal cross‑functional teams (QA, QC, Regulatory, R&D, and Supply Chain) to ensure robust, compliant, and efficient manufacturing operations. This position reports into senior CMC leadership and plays a critical role in ensuring technical excellence, regulatory compliance, and continuous improvement across Axsome’s drug substance portfolio. This role is based at Axsome’s HQ in New York City with an on‑site requirement of at least three days per week. Fully remote candidates cannot be considered. Job Responsibilities and Duties include, but are not limited to, the following: Lead and support day‑to‑day technical operations for commercial drug substance manufacturing in compliance with cGMP, FDA, EMA, and ICH guidelines Prepare, review, and approve technology transfer documentation, validation protocols, and final reports for new and existing products Provide technical leadership for process performance qualification (PPQ), scale‑up activities, and manufacturing readiness at internal and external sites Develop, review, and maintain Continued Process Verification (CPV) programs, including statistical trending, control charting, and process capability analysis Apply advanced statistical tools to assess process capability, identify trends, and drive data‑driven continuous improvement initiatives Lead and support investigations related to OOS/OOT results, deviations, and non‑conformances, including root cause analysis and CAPA implementation Perform risk assessments and develop mitigation strategies for process changes, equipment modifications, and supplier or raw material changes Support drug substance process development, optimization, troubleshooting, and technical transfer for mid‑ to late‑stage development programs Author and review Module 3 sections of regulatory submissions, including post‑approval changes related to scale, equipment, materials, and manufacturing processes Provide technical oversight and management of external CDMOs, ensuring alignment with quality, regulatory, and project timeline expectations Collaborate with QA, QC, Regulatory Affairs, R&D, and Supply Chain to resolve technical issues and ensure operational excellence Initiate and approve change controls, SOPs, and supporting GMP documentation as required Maintain current technical knowledge by evaluating and implementing new technologies, industry best practices, and regulatory expectations Design and lead technical investigations, interpret complex data sets, and provide clear recommendations for troubleshooting and next steps Requirements / Qualifications BS, MS, or PhD in Chemical Engineering, Chemistry, or a related technical discipline MS or PhD with 6–8+ years of directly related experience in pharmaceutical drug substance manufacturing, MSAT, or technical services; or Bachelor’s degree with 10+ years of directly related experience in small‑molecule drug substance manufacturing or technical operation Demonstrated hands‑on experience supporting commercial drug substance manufacturing and process validation activities Ability to work on‑site Monday, Tuesday, and Thursday at Axsome’s New York City headquarters. Willingness to travel periodically as required Experience, Knowledge and Skills Advanced knowledge of small‑molecule drug substance processing, including technology transfer, commercial manufacturing, and unit operations Hands‑on experience with PPQ, CPV, and post‑approval change management is required; pre‑approval process development experience is highly preferred Deep technical understanding of CPPs, CQAs, IPCs, and drug substance process transfer fundamentals Solid‑state chemistry and particle engineering experience is strongly preferred Experience supporting FDA and global regulatory submissions, including post‑approval change applications Detailed understanding of drug substance manufacturing floor operations and practical execution of cGMP requirements Proficiency with statistical software and application of statistical methods for process monitoring, trending, and improvement Experience with unit operation modeling and process simulation tools is a plus Strong working knowledge of cGMP regulations, FDA expectations, and SOP governance Demonstrated ability to lead technical discussions, influence cross‑functional stakeholders, and manage external manufacturing partners Salary and Benefits: The anticipated salary range for this role is $175,000 - $215,000. 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.