GxP Lab Specialist (w/m/d) Lab Immuno-Monitoring

Design. Progress. Together.

 

CureVac AG is a global biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on prophylactic vaccines, innovative cancer immunotherapies and protein-based therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

 

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a

 

GxP Lab Specialist (w/m/d) Lab Immuno-Monitoring

 

 Your responsibilities:

 

  • Ensure that laboratory processes of the clinical biomarker & immuno-monitoring unit are in compliance with the GCP regulatory requirements for laboratory analysis in clinical trials.
  • Validation of computerized systems used for analysis of clinical samples
  • Qualification of laboratory equipment in the laboratory
  • Coordination of instrument maintenance services with external contractors
  • Review and creation of new SOPs as needed
  • Management of risk assessment
  • Participate in the change control process to ensure changes to processes, systems and equipment
  • Preparation of and participation in internal audits and inspections, and follow-up of CAPAs
  • Archiving of relevant trial documents and source data in agreement with the scientists in charge
  • Interaction with lab technicians, QA/QM, facility management, IT, technical supportive functions and external vendors

 

 Your qualifications:

 

  • Bachelor’s or master’s degree in the biological/biochemical sciences, or equivalent
  • Experience in working in bioanalytical laboratory is desirable
  • Good knowledge in working in regulated GxP environments
  • Experience in validation and qualification of laboratory devices, writing and management of SOPs is desirable
  • Preferably experience in change control and CAPAs
  • Demonstrated independent and reliable laboratory work
  • Fluency in English; German is a plus

 

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us – become part of the RNA people!   

We look forward to receiving your application via our CareerPortal.

 

CureVac AG

 

Human Resources
Alexander Siller 
Friedrich-Miescher-Straße 15
72076 Tübingen