Director, CMC Drug Substance Manufacturing

About the Role >>> Director, CMC Drug Substance Manufacturing

As the Director, CMC Drug Substance Manufacturing reporting to the Sr Director, Drug Substance Development and Manufacturing, you will provide technical leadership and hands-on execution to support late-stage development, technology transfer to CDMOs, and commercial readiness including NDA filing for small molecule drug substances. This role is critical to ensuring successful scale-up, validation, and regulatory approval of drug substance processes. The individual will work cross-functionally and externally with CDMOs to deliver robust, compliant, and efficient manufacturing processes suitable for commercial supply.

This role is based out of our Dublin, Ireland office and will require 10-15% travel.

Your work will primarily encompass:

• Lead technology transfer of drug substance processes (RSM/API) to CDMOs, including strategy, execution, and risk management to support late-stage development and commercial manufacturing
• Provide technical oversight of CDMO activities, including process validation, manufacturing campaigns, and on-site support; serve as the primary technical point of contact
• Review and approve key manufacturing and development documentation (batch records, protocols, reports, specifications, and deviations) to ensure compliance and data integrity
• Lead deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs) to support reliable manufacturing performance
• Drive process robustness, control strategy development (e.g., DOE, PAR), and PPQ readiness to enable successful validation and commercial supply
• Leverage process and manufacturing data to enhance process understanding, monitor performance across sites, and identify opportunities for continuous improvement
• Support commercial supply readiness, including supply continuity, cost of goods optimization, and lifecycle management activities
• Author and review CMC sections of IND/NDA submissions, and support regulatory interactions, responses, and inspection readiness
• Identify technical risks and proactively develop mitigation strategies to ensure timelines for NDA filing and commercial launch are achieved
• Partner cross-functionally with Quality, Regulatory, Analytical, Drug Product, and Supply Chain to ensure aligned execution and compliance with global regulatory requirements

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge and experience:

• Ph.D. in Organic Chemistry or related discipline with ~10+ years of experience (or M.S. with ~15+ years) in small molecule CMC drug substance development and manufacturing
• Demonstrated experience leading technology transfer, scale-up, and validation of API processes to GMP manufacturing sites for late-stage and commercial programs
• Strong experience managing CDMOs, including vendor selection, technical oversight, and delivery of manufacturing campaigns aligned with quality, timeline, and cost objectives
• Proven success authoring and reviewing CMC sections of INDs, IMPDs, and NDAs/MAAs, and supporting regulatory interactions and responses with health authorities
• Strong technical foundation in small molecule process development, manufacturing, and control strategy, including DOE, PAR, and impurity control (e.g., fate and purge)
• Deep understanding of cGMP requirements and global regulatory expectations (ICH guidelines), with experience supporting inspection readiness and compliant manufacturing execution
• Demonstrated ability to identify technical risks and apply risk-based decision-making to drive timely and practical solutions
• Experience integrating process and manufacturing data to support process understanding, trend analysis, and continuous improvement
• Strong project management and communication skills, with the ability to influence cross-functional teams and external partners in a matrixed environment

Attributes:

• Curious, scientifically rigorous, and proactive with a strong "can-do" mindset
• Self-motivated and accountable, able to work independently and drive results
• Effective collaborator across cross-functional teams and external partners
• Highly analytical and detail-oriented, with a data-driven approach
• Organized and execution-focused, able to manage multiple priorities and timelines
• Committed to high scientific, quality, and ethical standards while driving continuous improvement

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