Within this role, you will perform assay transfers, validation and investigation activities for QC.
Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Key Responsibilities
* Performing assay validation for QC
* Reviewing new test procedures and assays
* Evaluating and bringing in new methodologies, techniques, and equipment as needed
* Generating and/or supporting the completion of compliance records, CAPAs, change controls and deviation notifications as needed
* Evaluating assay performance through yearly method performance reports
* Facilitating assay transfers from R&D and to business partners
* Organising analytical assay transfer internally and externally
* Performing additional studies supporting regulatory filing, e.g. bridging/comparability studies
Requirements
You must have a PhD in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries; an MSc with 7+ years of proven experience; or a BSc, which will be considered based on the candidate's years of experience and technical background, particularly within the pharmaceutical or biotechnology sectors.
This is a Senior QC Specialist role that requires you to work in a fast-paced environment, balance multiple projects, prioritize them and complete them independently, while keeping all impacted parties well advised.
As a team player, you will also take ownership of large technical reports and projects, develop and drive scientific and/or business-related improvement ideas, and participate in cross-functional improvement initiatives/kaizens.