Director, Drug Substance Commercialisation & Development – Ballydine, Co. Tipperary
We have an exciting opportunity for a skilled leader to provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients (APIs) at our primary Drug Substance commercialisation hub.
Key Responsibilities
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.
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.
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.
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.
Lead, develop, and inspire a team of technical leaders and specialists; build organization capability, succession plans, and technical depth.
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.
Anticipate challenges, escalates risks effectively, and delivers pragmatic, compliant solutions.
Understand interdependencies across clinical development, CMC, manufacturing, and supply chain to enable successful launches and stable supply.
Communicate with clarity and authority, building trust and alignment across cross‑functional and external stakeholders.
Champion 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 of experience 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.
Requisition ID: R394934
#J-18808-Ljbffr