This leading pharmaceutical organisation employs approximately 20,000 employees globally with revenues of over 8 billion per annum. They are a speciality pharmaceutical company that develops and markets prescription and non-prescription pharmaceutical products that make a meaningful difference in patients' lives. Specifically focussed on dermatology, eye health and other niche therapeutic areas targeting growth markets around the world, this innovator is a diverse and decentralised organisation committed to focusing on their key stakeholders while delivering consistently high performance. Based at their corporate offices in Dublin, a new position has arisen for an Associate Director of Technical Operations primarily focussed on the organisations EU business.

The Role

The Associate Director of Technical Operations will provide technical support to R&D support during manufacturing scale-up, process/packaging validation and launch of new products at external manufacturing organisations (EMOs). In addition you will:

• Provide technical research and process knowledge in the implementation of change controls and technical transfers
• Monitor process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control
• In collaboration with Quality, support the accurate execution of routine process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs)
• Support a continuous process verification program for assigned projects via the collection and trend analysis of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) at EMOs
• Collect and analyse key performance indicators (KPIs) to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues
• Provide scientific leadership of technology transfers to/from external manufacturing sites to ensure right first time transfers
• Author technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes)
• Contribute scientific guidance during process/product deviations, out-of-trend/out-of-specification (OOT/OOS) investigations and product complaints

The Person

• Bachelor's degree in in Chemistry, Chemical Engineering, or Pharmaceutical Chemistry with minimum 7 years' experience or Master's Degree with 5-7 years' experience or PhD with 3-5 years' experience in Pharmaceutical Technical Services encompassing Technical Transfer, Technical Trouble Shooting and Process Optimisation
• CMC Subject Matter Expertise across a broad range of pharmaceutical dosage forms

To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.