Senior Manager Technical Operations

Role: Senior Manager of Technical Operations overseeing drug product manufacturing for Lupkynis, focusing on process transfer, validation, and optimization to ensure high-quality, cost-effective CMC activities. Responsibilities: lead external manufacturing and development activities, including formulation, process development, and clinical batch production; coordinate with CDMOs and cross-functional teams (R&D, QA, Regulatory) for technical transfer, risk mitigation, and regulatory documentation; support late-stage CMC activities such as process characterization and validation; and contribute to regulatory filings. Requirements: minimum 10 years in drug formulation, solid oral dosage development, or manufacturing, with a BS/MS (PhD preferred) in Organic Chemistry or Pharmaceutical Sciences; extensive experience in formulation, encapsulation, and process development. High-value: biologics or small molecules in autoimmune indications, with a focus on oral dosage forms, CGMP manufacturing, and regulatory submissions. Collaboration includes external CDMOs and internal R&D, QA, and Regulatory teams. Travel: up to 25%. Work setup: not explicitly stated but involves coordination with external vendors and internal teams.