Senior Scientist, Quality Control

4 months ago

Gladsaxe Kommune, Denmark AGC Biologics Full time

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you motivated by leading and participating in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you

The Department
QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry has a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.

Roles and Responsibilities
As (Senior) Scientist and subject matter expert for validations in QC Chemistry, it is required that you have expertise and ability to troubleshoot chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. 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. Since you will participate in method relevant Customer meetings and provide input for validation planning, good communication skills are essential together with a general understanding of planning and coordination of activities.

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 important to have a self-motivating personality with a pragmatic, solution-oriented approach to daily work, without compromising quality. Furthermore, you thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team. You bring a positive, can-do attitude and a good sense of humor.

Location: Copenhagen Site

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