Senior Quality Control Specialist
2 weeks ago
Our mission at AGC Biologics is to improve patients' lives by bringing new biopharmaceuticals to market.
We are seeking a highly motivated and experienced Senior Scientist to lead and participate in the coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide.
The Department
QC Chemistry is one of five departments in the QC area, responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines.
Roles and Responsibilities
As a Senior Scientist and subject matter expert for validations in QC Chemistry, you will be driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs, and running Lab Investigations, Deviations/CAPAs and CR cases.
Your Profile
The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has a minimum of 3 years of work experience in analytical development or quality control.
In addition, you ideally bring some of the following experience and characteristics:
- Working and troubleshooting experience with SE-, IEX- and RP-UHPLC, iCIEF and CGE-SDS analysis.
- Experience with Chromeleon software and LIMS.
- Technical experience in protein analytics testing and protein biochemistry.
- Experience in validating analytical methods according to ICH guidelines for PhI/II and/or PhIII.
- Experience with working in cGMP settings according to European and US regulatory guidelines.
- Excellent communication, presentation, and interpersonal skills.
- You like to share your knowledge and communicate openly and professionally both internally and with external customers.
- You are able to prioritize your own tasks in a dynamic environment.
- You are a team player with the ability to work independently.
- Fluent in written and spoken English.
It is essential to have a self-motivating personality with a pragmatic, solution-oriented approach to daily work, without compromising quality.
Location: Copenhagen Site
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