Senior Director, Drug Substance Process Development

Innoviva Specialty Therapeutics, Inc.; Waltham (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Innoviva Specialty Therapeutics, Inc. is seeking a Senior Director of Drug Substance Process Development to lead CMO manufacturing activities, drive process development, scale-up, and technology transfer for commercial drug substances, and oversee CPV programs.

Collaboration with CMC, Quality, Regulatory, and external partners is essential to ensure GMP compliance and successful product lifecycle management.

Qualifications

• Advanced degree in Chemical Engineering or Chemistry.
• 15+ years of CMC experience in small molecule development.
• Vendor oversight of outsourced “virtual manufacturing” environment.
• Up-to-date knowledge of ICH and FDA guidance related to pharmaceutical development and manufacturing.

Responsibilities

• Lead and coordinate CMO cGMP manufacturing activities including 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.

Skills

Communication skills

Stakeholder engagement

Process development

Technology transfer

Project management

Six Sigma

Education

Master's or PhD in Chemical Engineering or Chemistry

Tools

HPLC

GC

IR

MS

NMR

Job description

Innoviva Specialty Therapeutics, Inc. is seeking a Senior Director of Drug Substance Process Development to lead CMO manufacturing activities, drive process development, scale-up, and technology transfer for commercial drug substances, and oversee CPV programs.

Collaboration with CMC, Quality, Regulatory, and external partners is essential to ensure GMP compliance and successful product lifecycle management.