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 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
- 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.