Qualifications

• PhD in Analytical Chemistry or related field preferred, with 10+ years in CMC analytical development of small molecules.
• Experience in developing impurity control strategies, specifically for PMIs and nitrosamines.
• In-depth knowledge of late-phase method development, validation, and characterization of small molecules.
• Proficient in HPLC, GC, MS, NMR, and several other analytical techniques.
• Familiarity with compendial testing methods (USP/EP) for drug substance and product.
• Skilled in managing cGMP stability studies at external labs.
• Strong understanding of GLP, cGMP, and ICH requirements.

Responsibilities

• Execute development and validation of critical analytical methods including HPLC and GC.
• Ensure analytical methods and specs are robust for late-stage drug development.
• Collaborate with CMC scientists on impurity characterization and testing results.
• Design and oversee ICH stability programs for drug substances and products.
• Manage daily analytical development activities at CDMOs and contract labs.
• Enhance internal lab capabilities for analytical processes.
• Prepare and review GMP documentation and support investigations of nonconformances.
• Participate in drafting analytical sections of late-phase regulatory submissions.
• Engage with health authorities on analytical queries and compliance.

Benefits

• Competitive compensation package recognizing performance and results.
• Eligibility for annual bonuses and equity participation.
• Comprehensive health benefits.