Career Category
Process DevelopmentJob Description
Job Posting Title Sr Associate Tech Engineering - Drug Process Development
Career Category Process Development
Employee Subgroup TBC
Country (State/Region) Ireland
Location (City) Ireland - ADL
What will you do
- The candidate will be responsible for supporting small and large molecule drug product manufacturing at Amgen Dun Laoghaire. As part of our global Process Development organization they will be key in ensuring the highest standards of process performance, while providing process and product support to drug product formulation and fill-finish operations at ADL.
- Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, for parenteral products.
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Support subject matter experts with recipe development and protocol execution, as well as troubleshooting and investigation support.
- Supports the characterisation of drug product processes and transfer of new technologies to commercial sterile fill/finish sites.
- Review and approve changes to operating procedures, electronic batch records and process documentation.
- Support product impact assessments associated with process excursions and deviations with reference to product technical documentation.
- Data trend analysis for all performance aspects of the area.
- Authors and reviews technical protocols, reports and product impact assessments
Basic Qualifications
• Bachelors degree in Science, Engineering or relevant discipline with 2- 3 years experience in a similar role OR
• Masters degree & 2 years of directly related experience
• Knowledge of aseptic manufacturing technologies and cGMPs
Preferred Qualifications
• Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
• 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
• Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
• Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilisation would be an advantage.
• Demonstrated ability working cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.
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