Full-Time

Associate Director/Director

Drug Product Technical Operations

Confirmed live in the last 24 hours

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops therapies for central nervous system conditions

Biotechnology

Compensation Overview

$150k - $180kAnnually

+ Annual Bonus + Significant Equity + Generous Benefits Package

Senior

New York, NY, USA

Required Skills
Data Analysis
Requirements
  • Bachelor’s, Master’s or Ph.D. degree in pharmaceutical sciences, chemical engineering, or a relevant scientific/engineering discipline
  • Minimum of 8-10 years of experience in commercial drug product manufacturing
  • Solid knowledge and understanding of CMC and process development
  • Experience in external vendor management and working with contract manufacturing organizations (CMOs)
  • Proficiency in utilizing statistical software tools such as JMP and Minitab
  • Excellent communication skills
  • Exceptional organizational skills with the ability to multi-task and prioritize workload
  • Willingness to travel periodically
  • Ability to work on site Monday, Tuesday & Thursday
Responsibilities
  • Develop and implement strategic plans to support drug product development, commercial manufacturing, supply, and global submission goals
  • Oversee drug product manufacturing processes and ensure efficient and robust commercial manufacturing operations
  • Provide technical expertise on various solid dosage unit processes
  • Review batch records and investigations related to manufacturing deviations and quality incidents
  • Collaborate with cross-functional teams to drive alignment and successful product development
  • Implement best practices, process improvements, and advanced manufacturing technologies
  • Participate in process validation activities for drug product manufacturing
  • Establish in-process control strategy and continued process verification program
  • Implement statistical process control techniques and data analysis
  • Provide technical expertise and support for regulatory submissions
  • Manage relationships with contract manufacturing organizations
  • Collaborate with QA team to provide oversight and audit support

Axsome Therapeutics Inc

Axsome Therapeutics Inc

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With a dedicated focus on developing therapies for central nervous system conditions—such as depression, Alzheimer’s disease agitation, and fibromyalgia—this company stands out by addressing critical unmet medical needs with promising products like AXS-05 and AXS-07. The firm fosters a culture deeply committed to innovation and the development of therapies with novel mechanisms of action, showcasing strong potential in the medical field and enhancing patient care in areas with limited treatment options.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

12%

1 year growth

45%

2 year growth

277%