Associate Director/Director, Drug Product Technical Operations

2 days ago

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Axsome Therapeutics, Inc.

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Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options$1. .$1

Biopharmaceuticals • Pain • CNS • Narcolepsy • Major Depressive Disorder

201 - 500

💰 $200M Post-IPO Equity on 2019-12

Description

• Develop and implement strategic plans for drug product development and manufacturing goals • Oversee drug product manufacturing processes for efficient operations • Author process validation protocols and reports for commercial products • Facilitate technology transfer from R&D to manufacturing • Review commercial batch records and investigations related to manufacturing deviations • Collaborate with cross-functional teams to ensure successful product launch • Maintain in-process control strategy and continued process verification (CPV) program • Author comprehensive CPV protocols and analyze data for improvements • Implement best practices and process improvements in manufacturing • Participate in process validation activities and statistical analysis • Provide expertise for regulatory submissions related to drug product manufacturing • Manage relationships with contract manufacturing organizations (CMOs) • Collaborate with QA for CMO audit support

Requirements

• Advanced degree (Ph.D., M.Sc., or equivalent) in pharmaceutical sciences, chemical engineering, or a relevant scientific/engineering discipline • A minimum of 10 years of experience in commercial drug product manufacturing • Strong experience in external vendor management and working with contract manufacturing organizations (CMOs). • Proficiency in utilizing statistical software tools such as JMP and Minitab. • Ability to work on site Monday, Tuesday & Thursday

Benefits

• Annual bonus • Significant equity • Generous benefits package