Director, Drug Substance Commercialisation & Development

Director, Drug Substance Commercialisation & Development - Ballydine, Co. Tipperary.

The Director will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients (APIs). This role carries end to end accountability for drug substance commercialisation activities at Ballydine, including process development, scale up, validation, and lifecycle management.

Key Responsibilities

• Strategic & Functional Leadership

  As a member of the Commercialisation Leadership Team, define, own, and implement the drug substance commercialisation strategy for the site and assigned portfolio. Provide senior technical authority for API commercialisation decisions impacting safety, quality, regulatory compliance, cost, timelines, and supply reliability. Lead technical support for commercialisation activities across multiple clinical and commercial processes, ensuring alignment with product and portfolio strategies.

• Process Development & Commercialisation

  Direct process development, optimisation, and scale up activities, including evaluation of raw materials, route selection, and process fit for commercial manufacture. Provide leadership for pre PPQ, PPQ, and commercial production campaigns, ensuring robust process performance and operational readiness. Approve campaign preparation and follow up activities, including safety and environmental assessments, batch records, validation strategies, and regulatory compliance. Oversee process monitoring, cycle time analysis, deviation investigations, and definition of cleaning and control strategies.

• Technical Oversight & Risk Management

  Direct chemistry and engineering support for new and existing clinical and commercial processes, evaluating scale up, plant operability, EHS, and sustainability impacts. Proactively identify, assess, and mitigate technical, operational, and supply risks, escalating and resolving issues at an enterprise level when required. Ensure laboratory and manufacturing activities are conducted safely and in compliance with cGMP, GLP, and corporate standards.

• Network & External Engagement

  Lead and govern transfers of drug substance processes to internal sites and external manufacturing partners. Act as a senior technical interface with external partners, regulators, and auditors, supporting submissions, inspections, and technical exchanges. Ensure assigned processes and systems meet site, divisional, and corporate quality standards and support regulatory and customer commitments.

• People, Capability & Business Leadership

  Lead, develop, and inspire a team of technical leaders and specialists; build organization capability, succession plans, and technical depth. Delegate with clear accountability, provide coaching and feedback, and create growth opportunities across technical and leadership dimensions. Contribute to resource planning, budget management, R&D tax reporting, and departmental administration as part of the Technical Leadership Team.

Core Competencies & Functional Leadership

• Recognised subject matter expert in drug substance process development and commercialisation.
• Strong understanding of CMC strategy, late stage development, and product lifecycle management.
• Ability to synthesize complex technical data and influence senior program and portfolio decisions.
• Drive execution through others, translating strategy into clear priorities, governance, and accountability.
• Anticipates challenges, escalates risks effectively, and delivers pragmatic, compliant solutions.
• Understands interdependencies across clinical development, CMC, manufacturing, and supply chain.
• Communicates with clarity and authority, building trust and alignment across cross functional and external stakeholders.
• Champions innovation, continuous improvement, and alternative approaches to achieve business and technical outcomes.

Your Profile

• Degree (BSc/BEng/Masters) or higher (PhD) in Chemistry/Pharmacy or Chemical/Process Engineering.
• Minimum 15 years in process chemistry, chemical engineering, and API commercial manufacture.
• Strong background in process, equipment, and cleaning validation.
• In depth knowledge of cGMP manufacturing operations and regulatory expectations.
• Experience with electronic batch records and control systems (e.g., DeltaV).
• Proven capability in deviation management, inspection readiness, and regulatory interactions.
• Demonstrated experience in financial management, budgeting, and resource planning.
• Knowledge of HR processes, training systems, process safety management, and environmental compliance.
• Excellent written, verbal, and executive level communication skills.
• Strong cross functional leadership, strategic thinking, project execution, and lean / continuous improvement mindset.

Required Skills

• Capital Management
• Change Management
• Chemical Engineering
• Cross Cultural Awareness
• Cross Functional Leadership
• Decision Making
• Financial ManagementGMP Compliance
• Innovation
• Organizational Development (OD)
• Process Improvements
• Product Lifecycle
• Results Oriented
• Safety Management
• Strategic Thinking
• Technical Leadership

Preferred Skills

• Manufacturing