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Axsome Therapeutics, Inc. · 1 month ago

Associate Manager/Manager, Technical Operations

New York, NY

Full-time

Onsite

Mid, Senior Level

$100K/yr - $135K/yr

4+ years exp

Axsome Therapeutics is a biopharmaceutical company focused on advancing treatments for CNS conditions. They are seeking an Associate Manager, Technical Operations to lead technical operations for drug product manufacturing, ensuring compliance with regulatory standards and driving process improvements.

BiopharmaBiotechnologyTherapeutics

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, Statistical Process Control) for data-driven decision-making and process improvement

Initiate and review change controls and SOPs as needed

Qualification

Pharmaceutical manufacturingProcess validationStatistical methodsCGMP complianceFDA submissionsTechnical transferStatistical softwareRisk assessmentCross-functional collaborationTechnical leadership

Required

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