A unique opportunity has arisen to join a leading global specialty pharmaceutical company that focusses on acquiring prescription medicines across a broad range of therapetuic areas in international markets and optimising these established medicines. Headquartered here in Ireland, this organisation is currently undergoing significant expansion and with this expansion a new requirement in the organisation has arisen for a Global API Technical Operations Lead which will offer the successful candidate the ability to lead all API technical transfers and associated activities for the businesses externally manufactured active pharmaceutical ingredients.
- Lead and manage / coordinate the API transfer (chemical synthesis).
- Assess manufacturing requirements, capabilities and budgetary requirements prior to the transfer using SMART methodology (Specific, Measurable, Accurate, Realistic and Timely)
- Review and approve technology transfer protocols and reports, manage document exchange between the existing API manufacturing sites and the new manufacturing site, generate change control records, deviations, CAPAs, etc. to support the transfer.
- Provide process transfer support to the API manufacturing, including generation of process descriptions and facility fit comparisons.
- Track project activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
- Prepare, distribute and present project status reports to the organisations Leadership team.
- Review and approval of API manufacturers batch records and testing methods. Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
- 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 contract API manufacturing organisations.
- Contributes scientific guidance during process/product deviations, out-of-trend/ out-of-specification (OOT/OOS) investigations and product complaints.
- Use scientific and statistical analyses (of KPIs) to develop process understanding. Uses knowledge further in root cause analysis investigations.
- Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products.
- Manage external API manufacturer post transfer activities. Including management of contracts (initially and reviews thereafter), assessment of events such as deviations, OOS, change controls, APQR.
- Provides technical research and process knowledge in the implementation of change controls and technical transfers.
- Bachelor's degree in in Chemistry, Chemical Engineering, or Pharmaceutical Chemistry with minimum 8 years of experience or Master's Degree with 6 years of experience or Ph.D. with 4 years of experience in Pharmaceutical Technical Services/Operations encompassing Technical Transfers.
- Experience in a similar role to that defined is a distinct advantage.
- Experience in project management, including budgetary requirements a distinct advantage.
- CMC Subject Matter Expertise across API manufacturing
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion