Associate Director, CMC Technical Writer at Axsome Therapeutics Inc

Brisbane, 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

MS in Chemistry, Biochemistry, or related discipline with a minimum of 6+ years or BS in Chemistry, Biochemistry, or related discipline with a minimum of 8+ years of experience in clinical-stage biopharma with a proven technical track record in technical writing supporting CMC for Biologics
Experience authoring and reviewing a diverse set of technical documents including technical reports, manuscripts, regulatory filings including BLA/MAA across a broad technical background (analytical, process development, manufacturing)
Experience working with contract service providers is a plus
Effective communication and documentation skills
Strong attention to detail and organization
Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment
Candidates must be authorized to work in the U.S

Responsibilities

Author and review internal documents including protocols, reports, SOPs, deviations, change controls, and manuscripts in support of all CMC functions
Work closely with the members of the CMC and Regulatory functions to author and review regulatory documents including IND/IMPD/BLA/MAA sections and meeting packages
Collaborate with CMC, Quality, and Regulatory colleagues to develop story boards for inspections and responses to information requests
Review external documents from Vera’s supply chain network
Develop document templates and workflows for technical documents

Skills

CMC

Technical Writing

Regulatory Documents

Chemistry

Manufacturing

Controls

Quality Assurance

Analytical Sciences

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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