Senior Director, Drug Substance and Process Development

Responsibilities

• 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.
• Career 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.

Requirements

An advanced (Masters or PhD) degree in Chemical Engineering or Chemistry required

15 plus years of CMC experience in small molecule development and commercial manufacturing

Significant experience working in and providing vendor oversight of an outsourced “virtual manufacturing” environment

In-depth knowledge of industry manufacturing, quality, and regulatory practices in small molecules drug substance manufacturing and supply chain

Deep expertise in small molecule API development, manufacturing, and control strategies

Skills and Abilities

• Excellent communication and interpersonal skills, with the ability to effectively engage and influence a broad range of internal and external stakeholders at all levels of the organization.
• Experienced in process development, tech transfers, and clinical and commercial manufacture of drug substance processes and managing associated commercial production and activities.
• Strong understanding of typical unit operations and related drug substance process equipment.
• Experience and understanding of analytical methods related to drug substance manufacturing (i.e., HPLC, GC, IR, MS, NMR, etc.).
• Demonstrated expertise in process troubleshooting and application of continuous improvement methodologies (i.e., Six Sigma).
• Process R&D experience with development and scale-up, lab to plant, through all phases of development, process validation, and commercial manufacturing.
• Experience with implementing Quality by Design including DoE, fate and tolerance, and risk analysis.
• Up to date knowledge of ICH guidelines and FDA guidance’s related to pharmaceutical development, manufacturing, and stability of drug substance.
• Experience managing relationships, influencing and negotiating, and interacting in a matrix environment and with CMO drug substance manufacturers.
• A proven track record of delivering results and is action oriented.
• Proactive, strong organizational and time management skills.
• Willingness and ability to travel 10% to 20% domestic/international travel for interactions with CDMOs for critical project activities.