Associate Manager/Manager, Technical Operations

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 results-driven Associate Manager, Technical Operations with experience in pharmaceutical manufacturing and process validation that is adept in applying advanced statistical methods (ANOVA, MANOVA, process capability) to evaluate process consistency and improve quality outcomes.

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:

• Prepare and review technical transfer documents, validation protocols and reports

• Prepare and review Continued Process Verification (CPV) documents including statistical trending, control charting and process capability analysis and play a significant role in continuous improvement efforts

• Provide on-site support and technical leadership for tech transfer and scale up activities and of process performance qualification (PPQ) for new and existent products

• Lead and support day-to-day technical operations for commercial drug product manufacturing, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines

• Provide technical expertise for investigations of OOS/OOT, deviations, identifying root causes and implementing CAPAs

• Perform risk assessments and develop mitigation strategies for process changes, equipment modifications, and supplier changes

• Support post approval regulatory submissions by writing/reviewing relevant sections of regulatory dossiers

• Work with the internal and external drug product teams and manufacturing site technical leads to develop and communicate tech transfer plans

• Collaborate with cross-functional teams (QA, QC, Regulatory, R&D, Supply Chain) to resolve technical issues and drive operational excellence

• Ensure a high level of current technical knowledge is maintained within the development team by implementing new technical developments and practices in the industry as required and where needed

• Design complex technical projects or investigations, interpret diverse data and results, and provide recommendations for the next steps

• Implement statistical tools (ANOVA, Statistical Process Control) for data-driven decision-making and process improvement
• Initiate and review change controls and SOPs as needed

Requirements / Qualifications

• Master’s Degree in chemical engineering or pharmaceutical engineering with minimum of 4 years of directly related experience in a Technical Services function within the Pharmaceutical industry or a Bachelor’s Degree in chemical engineering or pharmaceutical engineering with minimum of 6 years of directly related experience in a Technical Services function within the Pharmaceutical industry

• Advanced knowledge of the standards and concepts applicable to a wide range of work in pharmaceutical dosage processing including the areas of tech transfer, commercial manufacturing, and unit operations

• Hands on experience in commercial drug product manufacturing/packaging equipment and processes, post-approval change projects and process validation

• 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

• Experience with FDA submissions for post-approval change applications

• Detailed knowledge of drug product manufacturing floor activities

• Experienced with use of statistical software to analyze process related data

• Strong hands-on cGMP and FDA regulatory and SOP knowledge

Salary & Benefits

The anticipated salary range for this role is $100,000 - $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.