Innoviva Specialty Therapeutics, Inc.

Director

• Lead and coordinate CMO cGMP manufacturing activities including but not limited to scheduling, production, process transfer, validation, cleaning, and supply chain logistics.
• Support and lead chemistry and engineering development of drug substance processes with focus on manufacturing process development, scale-up, process optimization, technology transfer and validation for commercial manufacturing.
• Review commercial & clinical batch records, investigations related to manufacturing deviations, out-of- specification (OOS) results, and other quality-related incidents.
• Establish and maintain continued process verification (CPV) programs and KPI’s to ensure proactive control and monitoring utilizing process data analytics.
• Address technical and quality issues/investigations (Deviations, OOS, OOT) at CMO’s to assure GMP compliance prior to QA release; utilize IST quality systems to document review and oversight.
• Coordinate cross-functional activities between CMC, Quality, Regulatory, EHS, Supply Chain, etc.
• Manage relationships with contract manufacturing partners and ensure that outsourced manufacturing operations meet established quality and delivery standards.
• Act as person in plant during key manufacturing operations, address technical and quality issues, and support audits and inspections.
• Utilize continuous improvement tools to develop route/production/cost improvement programs in collaboration with CMO team.
• Author and review drug substance CMC Module 3 sections including regulatory investigational (IND/CTA), registrational (NDA/MAA), and post approval submissions.

Senior Director, Drug Substance and Process Development