Senior Manager/Manager, Manufacturing at Axsome Therapeutics Inc

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s or Master’s degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience
Strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products (preferred)
Strong emphasis on quality event management and process improvement for manufacturing operations
Ability to create, read, review, and edit manufacturing related documents including Batch Records, SOP’s, Work Instructions and associated forms
Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment
Experience leading projects and managing teams
Ability to work subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels
Ability to work with cells and cell lines of human and/or animal origin, hazardous materials, and in controlled and cGMP Manufacturing environments requiring special gowning

Responsibilities

Oversee end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCB’s through harvest and cryopreservation of drug product
Work effectively with other groups including Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities
Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions
Assure manufacturing facility is maintained in an inspection-ready state at all times
Engage with Materials Management and Planning and Sourcing teams to assure adequate inventory of raw materials to support planned production activities
Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools
Assure manufacturing staff meet and maintain cGMP training requirements
Develop personnel schedules to allow effective execution of manufacturing activities
Review and approve applicable manufacturing-related documentation
Lead authorship and review process of SOPs and GMP BRs
Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes
May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently

Skills

Key technologies and capabilities for this role

GMPCAPADeviationsiPSCcell therapySmartSheetMicrosoft OfficecGMPProject ManagementQuality AssuranceSupply Chain

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a full-time, exempt position located at the corporate headquarters in San Diego, CA.

What qualifications are required for this role?

A Bachelor’s or Master’s degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required, along with experience leading projects and managing teams.

What salary or compensation does this position offer?

This information is not specified in the job description.

What does the team structure look like for this role?

The role is part of the Manufacturing Team and may involve hiring, overseeing, training, and motivating team members to meet goals efficiently.

What makes a strong candidate for this position?

Candidates with a strong manufacturing administration background in tech transfer of aseptically produced cell products, emphasis on quality event management and process improvement, and the ability to lead projects and teams in a fast-paced environment stand out.

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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