Associate Director Of Tech Operations
This leading Pharmaceutical organisation employs approximately circa 20,000 employee's globally with revenues north of 8 billion per annum. A specialty 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 Position: Provides technical support to R&D support during manufacturing scale-up, process/packaging validation and launch of new products at external manufacturing organisations (EMOs. Provides technical research and process knowledge in the implementation of change controls and technical transfers. Monitors process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control. In collaboration with Quality, supports the accurate execution of routine process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs. Supports 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. Collecting and analysing 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. Providing scientific leadership of technology transfers to/from external manufacturing sites to ensure right first time transfers. Authors technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes. Contributes 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 of experience or Master's Degree with 5-7 years of experience or Ph.D. with 3-5 years of experience in Pharmaceutical Technical Services encompassing Technical Transfer, Technical Trouble Shooting and Process Optimization. CMC Subject Matter Expertize 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. This job originally appeared on RecruitIreland.com.
157 days ago