Associate Director-Small Molecule, Analytical Development

Role: Associate Director, Analytical Development for Small Molecules, leading analytical method development and validation across various dosage forms from early research to commercialization. Responsibilities: develop analytical strategies, oversee external labs and technology transfer, review validation and regulatory documentation, support impurity assessments (nitrosamines, mutagens), and contribute to regulatory submissions (INDs, IMPDs, NDAs). Collaborate with cross-functional teams in QA, Regulatory, and Manufacturing; ensure compliance with cGxP, ICH, USP/EP/JP standards; evaluate emerging analytical technologies. Requirements: Bachelor’s in Chemistry or Biochemistry; 8+ years in pharmaceutical analytical development, with 5+ years managing external testing labs; hands-on experience with inhalation and small molecule dosage forms; expertise in impurity profiling, nitrosamine risk, and regulatory compliance. Preferred: experience with inhalation or combination products. High-Value: small molecule drug development, analytical lifecycle management, impurity assessment, regulatory submissions, cGxP compliance. Location: Bridgewater, NJ (onsite); minimal travel. Work setup emphasizes collaborative, hands-on laboratory engagement.