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  • DUBLIN 2
  • Job reference number:15350709
  • Client ID:RI/BBBH23465
  • Posted on:16-MAY-2018
  • Location:DUBLIN, DUBLIN
  • Job type:PERMANENT

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.

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