Director, Drug Substance Commercialisation & Development

Overview

We are seeking a Director to lead Drug Substance Commercialisation & Development at our Ballydine site in County Tipperary, Ireland. This senior role holds full responsibility for advancing the introduction, technical development, and commercial production of clinical and commercial active pharmaceutical ingredients (APIs). The Director will ensure seamless supply, continuous improvement, and organizational alignment with strategic goals.

Key Responsibilities

• As part of the Commercialisation Leadership Team, develop and execute the Drug Substance commercialisation roadmap for the site and portfolio.
• Serve as principal technical authority guiding API commercialisation decisions concerning safety, quality, regulatory compliance, cost, delivery timelines, and supply robustness.
• Lead technical oversight across clinical and commercial process commercialisation, ensuring product and portfolio consistency.
• Manage process development efforts including optimization, scale-up, raw material assessment, and route selection for commercial manufacture readiness.
• Supervise pre-PPQ, PPQ, and production runs, maintaining process performance and plant preparedness.
• Authorize campaign preparations including safety evaluations, batch documentation, validation approaches, and regulatory adherence.
• Oversee monitoring of process parameters, analyze cycle times, investigate deviations, and define cleaning and control protocols.
• Provide technical direction integrating chemistry and engineering support for clinical and commercial processes considering scalability, plant operations, environmental, health, safety, and sustainability aspects.
• Identify and mitigate technical, operational, and supply risks proactively, escalating as necessary to corporate leadership.
• Guarantee lab and manufacturing activities uphold safety, cGMP, GLP, and company standards.
• Lead and manage transfer of Drug Substance processes internally and externally, acting as the senior technical liaison with partners, regulators, and auditors.
• Ensure processes and systems comply with site, division, and corporate quality standards to meet regulatory and customer commitments.
• Lead, inspire, and develop technical leaders and specialists. Build capability, succession plans, and technical depth across teams.
• Delegate responsibilities with clear accountability and foster growth through coaching and feedback in technical and leadership skills.
• Participate in resource planning, budgeting, R&D tax reporting, and administrative functions as a key member of the Technical Leadership Team.
• Drive recruitment, assessment, and staff development while shaping site-wide organizational and people strategies.

Core Expertise

• Recognized as a subject matter expert in Drug Substance process development and commercialisation.
• Deep knowledge of CMC strategy, late-stage development, and product lifecycle management.
• Ability to analyze complex technical data and influence senior portfolio decisions.
• Effectively drive execution by converting strategy into clear priorities with governance and accountability.
• Anticipate challenges, appropriately manage risks, and implement practical, compliant solutions.
• Understand dependencies across clinical development, CMC, manufacturing, and supply chain to enable successful product launches and stable supply.
• Communicate clearly and authoritatively to build trust and alignment among cross-functional teams and external stakeholders.
• Champion innovation, continuous improvement, and alternative problem-solving to meet business and technical goals.

Candidate Profile

• Educational qualifications include a Bachelor’s, Master’s, or PhD in Chemistry, Pharmacy, or Chemical/Process Engineering.
• Minimum 15 years’ experience in process chemistry, chemical engineering, and API commercial manufacturing.
• Solid background with process validation, equipment qualification, and cleaning validation.
• Comprehensive understanding of cGMP manufacturing and relevant regulations.
• Experience with electronic batch records and process control systems, such as DeltaV.
• Proven track record in deviation management, inspection readiness, and regulatory interactions.
• Experience in financial oversight including budgeting and resource planning.
• Familiarity with human resources processes, training programs, process safety management, and environmental compliance.
• Excellent communication abilities, both written and verbal, adapted for executive-level engagement.
• Strong leadership in cross-functional settings with strategic thinking, project management, and continuous improvement mindset.

Additional Information

• This role requires adherence to safety and regulatory standards and involves interaction with external partners and regulatory authorities.
• The position is on-site at Ballydine with a hybrid work arrangement indicated.
• A valid driving license is expected.
• There is no mention of relocation or visa sponsorship support.
• Flexible travel requirements apply.
• The job posting will remain open until May 22, 2026.
• The company maintains a policy against unsolicited communications from search firms without an existing agreement.

Company Values

We place patients at the core of our mission, focusing on innovative treatments for critical healthcare challenges. Our inclusive culture fosters collaboration among talented individuals to accelerate breakthrough advancements.

If you aspire to create impactful healthcare solutions, lead a global healthcare organization, and empower your team to reach new scientific and technological heights, we invite you to apply.