Job Summary

• Manage and drive analytical development and quality control activities across small molecule drug discovery and development programs.
• Define CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product.
• Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product.

Matching Summary

Salary

Base: $225,000 - $250,000; Bonus/Equity: stock options, annual target bonus; Benefits: benefits

Skills & Requirements

Key Requirements

• BS, MS, or PhD degree in analytical chemistry or related field
• 16+ years (BS), 14+ years (MS), or 10+ years (PhD) of relevant industry experience
• Demonstrated expertise with analytical techniques for small molecules and oral solid dose products
• Proficient working knowledge of NMR and solid-state characterization techniques
• Demonstrated knowledge of ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia
• Ability to travel domestically and internationally as needed, up to 20%

Work Rights