Senior Manager, Commercial Packaging at Axsome Therapeutics Inc

Brisbane, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

MS in relevant life sciences or M Eng. in relevant engineering discipline preferred
Minimum of 5 years of Pharmaceutical/Biotechnology industry experience
Proven track record of strategic planning and execution in biologics packaging operations
Experience supporting product launches, directing packaging operations, and managing lifecycle changes of commercial packaged goods
Experience with artworks management
Experience with transport qualification of temperature controlled supply chains from Drug Substance to Finished Goods
Exceptional organizational and communication skills
Capability to communicate strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions
Outstanding leader

Responsibilities

Direct day-to-day external (CMO) packaging operations, including projection of material requirements, budgets, and timelines
Manage technical oversight and guidance to CMOs for packaging technology transfers, optimization, and cGMP packaging of biologics drug product in support of commercial supply
Act as subject matter expert and project manager for packaging process validation, shipping distribution validation both in real-world and laboratory simulation environments
Manage the transport qualification of temperature controlled shipment of goods across the end-to-end supply chain
Oversee and manage the operation and configuration of Level 4 Track-and-Trace systems. Understand market and regulatory requirements from FDA, EMA and other global jurisdictions
Manage the creation, update and obsoletion of printed components artwork partnering with Regulatory, Marketing, CMOs and third party printer/converters
Execute plans in accordance with cGMP, ICH, and FDA regulations
Write, update and review relevant sections for regulatory submissions
Partner with and maintain regular contact with key stakeholders including Drug Product, Analytical Sciences, Quality Assurance, Regulatory Affairs, Finance, and Program Management
Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents

Skills

Key technologies and capabilities for this role

Packaging OperationsContract Manufacturing OrganizationsCMO ManagementSupply Chain ManagementCMCQuality AssuranceRegulatory AffairsBiologics PackagingProduct LaunchStrategic Planning

Questions & Answers

Common questions about this position

What is the salary range for the Senior Manager, Commercial Packaging role?

This information is not specified in the job description.

Is this Senior Manager, Commercial Packaging position remote or on-site?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires a proven track record of strategic planning and execution in biologics packaging operations, experience supporting product launches, directing packaging operations, managing lifecycle changes of commercial packaged goods, artworks management, and transport qualification of temperature controlled supply chains. Exceptional organizational and communication skills are also needed to communicate strategic plans to upper management and manage cross-functional stakeholders.

What is the company culture like at Vera Therapeutics?

The company's values are the cornerstone of its culture, inspiring daily work and guiding hiring, mission advancement, and improving treatments for patients with immunological diseases.

What makes a strong candidate for the Senior Manager, Commercial Packaging position?

A strong candidate is an outstanding leader with proven experience in biologics packaging operations, including product launches, CMO management, process validation, shipping validation, artworks management, and temperature-controlled supply chains, along with exceptional organizational and communication skills.

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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