Senior Manager, Analytical Chemistry

📋 Description

• Owner of analytical CMC workstreams from preclinical to registration.
• Lead outsourced testing with CROs/CDMOs, manage budgets and timelines.
• Oversee method development/ qualification/ transfer and lifecycle management.
• Provide analytical oversight across materials and product testing programs.
• Review data, documentation, and ensure regulatory suitability.
• Collaborate with cross-functional teams to advance milestones.

🎯 Requirements

• PhD in Analytical Chemistry or related with 6+ yrs pharma/biotech exp; or MS 9+ yrs; BS 12+ yrs.
• Deep experience in analytical development and QC for small-molecule drugs.
• Proven vendor management with CROs/CDMOs in outsourced models.
• Strong skills in HPLC/UHPLC, dissolution, GC, spectroscopy, MS, and moisture analysis.
• Understanding of method development, validation, transfer, and lifecycle management.
• Knowledge of ICH, FDA, and global regulatory expectations; GLP/cGMP familiarity.

🎁 Benefits

• Full-time, remote position based in the United States.
• 40-hour week with program-aware flexibility.
• Salary $115,000–$135,000; compensation varies by location and experience.
• Benefits included; potential bonus/equity; growth through technical leadership.
• Work on innovative small-molecule programs; cross-functional collaboration.
• Opportunity to lead external scientific partners in a highly outsourced model.