Senior Manager, Analytical Development

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Requirements:

• Bachelor’s degree in Analytical Chemistry or related discipline, Master’s degree a plus.
• 10+ years of industry experience in Analytical Development for small molecule drug substance and solid oral drug products.
• Strong attention to detail and meticulous data review skills.
• Knowledge of US and EU cGMP requirements and drug substance testing standards.
• Involvement in reference standard management and stability oversight.
• Experience with CMC across all drug development phases preferred.

Responsibilities:

• Support analytical deliverables of CMC programs in conjunction with team members.
• Manage analytical testing in external networks, especially related to GMP drug substances and products.
• Review raw data, calculations, and method validation documents.
• Authorize analytical methods and reports, document and monitor change controls.
• Oversee CMC stability and reference standard programs.
• Monitor external providers to improve efficiency.
• Support the design of quality control strategies and stability studies.