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 inspected drug product operations at ADL.
* Independently perform design and qualification activities.
* Author and / or reviewer of protocols, reports and technical assessments.
* Supports make-a-batch exercises to determine facility fit and identify gaps in the Visual Inspection process.
* Supports New Product Introduction with visual inspection method development and AVI characterization for new inspection lines.
* Provides expertise on defects identified during batch inspection and supports defect library updates.
* Supports in the development of visual inspection team members by allowing new members to shadow them.
* Support in the characterisation and qualification of AVI vision recipes as part of process improvements.
* Provides support for manufacturing and commercial activities.
* Leads or assists in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Assists in troubleshooting issues with drug product processing technologies and equipment.
* Is Audit ready to support during GMP Audits.
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
* Experience in a regulated and or vision related work environment
Preferred Qualifications
* 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
* Should be interested in working in a team of like-minded inquisitive people who serve the operations team by providing solutions to their inspection needs
* Independent thinker with demonstrated skills working in teams
* Strong Interpersonal and communication skills
* Demonstrated problem solving skills and a thirst for finding the root cause to a given problem.
