Background: The Technical Services team is seeking an experienced Scientist to support the commercial production of Drug Substance batches from the suite 1 and suite 2 manufacturing facilities.
The successful candidate will work collaboratively with the broader Technical Services Teams to provide technical services that align with site business objectives.
The role involves transitioning efficiently between projects and/or managing multiple smaller projects at the same time.
This position reports to the Technical Services manager for the suite 1 and suite 2 sustaining team and is part of the site technical services group.
Job Responsibilities included but not limited to: Supporting the Operational Unit to ensure alignment with the plan of record.
This encompasses supporting investigations, enhancing process robustness, and driving projects focused on process and yield improvements.
The review, assessment and approval of supplier change notifications (SCNs).
Responsibilities may include preparing, reviewing, and executing protocols, as well as authoring supporting documentation for changes resulting from the SCNs.
Supporting the introduction of new or alternate raw materials or consumables.
Authoring/ reviewing sections of regulatory dossiers including health authority query responses Authoring/reviewing the annual continued verification reports for the product in the manufacturing in suite 1