Associate Manager, Technical Operations

Role Summary

Associate Manager, Technical Operations with experience in pharmaceutical manufacturing and process validation, adept at applying advanced statistical methods (ANOVA, MANOVA, process capability) to evaluate process consistency and improve quality outcomes. This role involves technical transfer, process validation, and continuous improvement activities, including on-site leadership of tech transfer and scale-up efforts. Based at Axsome’s headquarters in New York City with an on-site requirement of at least three days per week.

Responsibilities

• 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, t-test, regression, SPC) for data-driven decision-making and process improvement
• Initiate and review change controls and SOPs as needed

Qualifications

• Master’s Degree in chemical engineering or biotechnology 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 biotechnology 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
• Education-related content as required by the role

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

Additional Requirements

• 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