Axsome Therapeutics, Inc. · 1 month ago
Manager, Analytical Development
New York, NY
Contract
Onsite
Mid, Senior Level
$120K/yr - $135K/yr
5+ years expAxsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system conditions. They are seeking a Manager, Analytical Development to manage and coordinate analytical activities on multiple clinical development programs, requiring extensive hands-on laboratory experience and excellent time management skills.
BiopharmaBiotechnologyTherapeutics
Responsibilities
Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early phase drug substance (40%) and drug product (60%) small molecule solid oral formulation programs
Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages
Assist in authoring CMC sections for regulatory submissions
Manage drug substance and drug product stability programs (QC and technical review of stability data packages that includes raw data, and stability data trend analysis)
Assist in the development of standard operating procedures
Manage reference materials and reference standards inventory and (re)qualification testing
Qualification
Required
Bachelor's degree in Analytical Chemistry or Chemistry or related field with 5+ years' experience or MS/PhD with 3+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development
Knowledge of drug product solid oral dose formulations
Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size
Functional understanding of small molecule analytical development and associated regulatory and quality requirements
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Demonstrated experience in managing outsourced analytical activities
Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product
Experience working on commercial stage products highly valued
Excellent verbal and written communication skills
Excellent problem solving and interpersonal skills
Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities
Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently
Flexibility to accommodate multiple time zones as needed
Willingness to travel periodically as needed
Preferred
Hands on experience with LC-MS/MS and GC-MS is a plus
Benefits
Annual bonus
Significant equity
Generous benefits package
Company
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1B2025-05-13Post Ipo Debt· $570M
2023-06-28Post Ipo Equity· $225M
2019-12-23Post Ipo Equity· $200M
Leadership Team
H
Herriot Tabuteau
Chief Executive Officer
Recent News
2026-01-22
Clinical Trials Arena
2026-01-17
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