Job Opportunity
As a senior engineer in drug product development, you will play a pivotal role in creating and scaling production of drugs for clinical trials. You will collaborate with cross-functional teams to drive project success.
* Support global external operations and shanbally teams
* Develop process comparisons, risk assessments, and mitigate technical and manufacturing risks
* Author technical reports for process and product characterization
* Manage change control, deviations, and CAPAs through quality management systems
You will facilitate investigations, root cause analysis, data gathering/analysis, and provide technical assessments for deviations. Additionally, you will lead process improvement projects to ensure right-first-time delivery of new products and technologies.
The ideal candidate has hands-on experience in MSAT or process development and technology transfer, with a background in large-scale processing of biologic drug products. They should possess a strong understanding of regulatory requirements, proficient in technical writing, and demonstrate excellent organizational, interpersonal communication, and problem-solving skills.