Assoc. Director, Drug Substance Commercialisation

Job Description: We have an exciting opportunity for an Assoc. Director, Drug Substance Commercialisation for our site in Ballydine, Co. Tipperary. The successful candidate will manage the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients (APIs). You will lead process development and scale up activities, drive process improvements, and provide technical expertise to resolve significant processing issues. This role combines hands on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production. Our Ballydine site is the primary commercialisation facility within the network and the hub where new processes are scaled and brought to commercial manufacture. Our site supports the introduction and production of clinical and commercial APIs and the transfer of processes and technologies across internal sites and external partners.

Key Responsibilities

• Strategy development and implementation as a member of the Commercialisation Leadership Team.
• Lead technical support for commercialisation activities across clinical and commercial production, including multiple processes and process steps.
• Oversee evaluation of raw materials, process fits, optimisation of chemical API routes, and development for scale up.
• Approve campaign preparation and follow ups, conduct safety and environmental reviews, review batch records, and ensure regulatory and validation compliance.
• Conduct process monitoring and time cycle analysis, lead deviation investigations and resolutions, and define cleaning processes.
• Provide process leadership to production campaigns (pre PPQ and commercial).
• Direct chemistry and engineering support for process development activities for new clinical processes and beyond; evaluate scale up implications on plant operations, safety, and environment.
• Manage transfers of processes to other company sites or external partners as required.
• Ensure laboratory and operational activities are conducted safely and in compliance with current GMP and GLP requirements.
• Develop and coach team members-delegate appropriately, create growth opportunities, and provide technical, business, and performance guidance.
• Participate in departmental administration as part of the Technical Leadership Team, including workforce and resource planning, R&D tax reporting, and budget oversight.
• Contribute to recruitment, development, and assessment programs and support implementation of site human resources and organisational development plans.
• Ensure assigned processes and systems comply with site, divisional, and corporate quality standards and provide technical support for internal and external audits and submissions.

Functional Leadership

• Deep technical and subject matter expertise in process development and commercialisation.
• Solid understanding of new product development and commercialisation, including CMC (Chemistry, Manufacturing & Controls) considerations.
• Ability to analyse multiple data sources and influence programme decisions based on facts.
• Proactively identify and elevate risks, drive solutions.
• Translate priorities into actionable plans and hold teams accountable for delivery.
• Monitor progress to ensure deliverables meet agreed standards and methodologies.
• Contribute proactively to technical reviews and allocate resources to meet programme goals.
• Understand connectivity across clinical development, CMC, and supply chain to enable successful product launch and stable supply.
• Communicate effectively to build trust, provide coaching, and develop high performing teams.
• Encourage innovative problem solving and alternative approaches to achieve results.

Qualifications

• Degree (BSc/BEng) or higher in Chemistry or Chemical Engineering.
• Strong background in process chemistry and engineering principles.
• Experience with process, equipment, and cleaning validation.
• Knowledge of cGMPs and production operations.
• Familiarity with electronic batch records and control systems (e.g., DeltaV).
• Experience with deviation management systems and regulatory requirements.
• Financial management and budget awareness.
• Knowledge of HR, training, process safety management, and environmental policies and procedures.
• Excellent written and verbal presentation skills.
• Strong teamwork and cross functional collaboration abilities.
• Performance management, strategic thinking, project management, problem solving, and lean leadership experience.

Required Skills

• Accountability
• API Manufacturing
• Change Control Systems
• Chemical Process Development
• Clinical Development
• Clinical Trials
• Corporate Productions
• Cross Cultural Awareness
• Cross Functional Teamwork
• Delegation of Authority
• Environmental Research
• Equipment Qualification
• GMP Compliance
• Leadership
• Management Process
• Manufacturing Process Validation
• People Leadership
• Process Chemistry
• Process Improvements
• Process Optimization
• Production Process Development
• Production Support
• Regulatory Compliance
• Regulatory Inspections