Clinical Trial Lab Manager mfd

In the Clinical Trial Execution Service department your role will support our trial processes and activities in line with our gotomarket strategy for Investigational Medicinal Products (IMPs) especially in hematological and oncological indications. As a key contact for bioanalytical services in cell and gene therapy you will also serve as an expert for smooth logistics and analysis of  PK/PD/ immunogenicity/ Biomarker analytical methods at central labs for CART/gene therapy oncology clinical drug trials.

• Your responsibilities will include supporting our product candidate projects by identifying selecting and monitoring central clinical and bioanalytical laboratories.
• You will liaise with these laboratories and interdisciplinary project teams on selection of appropriate analytical technologies and on accurate interpretation of data for clinical decision making.
• You will oversee the development and validation of bioanalytical methods by coordinating with contract laboratories to evaluate the performance of analytical assays for PK/PD/ immunogenicity/ Biomarker in Phase IIII clinical trials.
• Furthermore you will support project teams by ensuring timely delivery of bioanalytical/ biomarker and clinical laboratory results.
• Additionally you will also be responsible for ensuring that documents related to method development transfer qualification and validation as well as lab manuals are prepared and updated.

Qualifications :

• You hold a Masters degree or ideally a PhD in Life Sciences such as biology or biochemistry. 
• Your professional background includes substantial experience in bioanalytical method development and validation particularly for PK/PD/ immunogenicity/ Biomarker analysis. You are accustomed to operating within regulated framework such as GCP/ GCLP and GLP.
• Your expertise encompasses a comprehensive understanding of the scientific regulatory and operational aspects necessary for conducting PK/PD/ immunogenicity/ Biomarker evaluations.
• You have foundational knowledge in pharmacokinetics and pharmacodynamics coupled ideally with experience in laboratory operations preferably within clinical trial research. Ideally you posses project management competencies as well as experience in supporting clinical documentation (e.g. CTP ICF validation plans/reports).
• Fluency in English is essential for communication while German language skills are beneficial. You thrive in collaborative interdisciplinary team settings working towards objectives with a positive outlook and appreciate a dynamic work environment with succinct communication channels.

Additional Information :

This position can be fiilled with 32h 40h per week

What we offer

• A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future. 
• Crossborder intercultural cooperation and short communication channels 
• A collegial corporate culture and flexible working hours enable time management on your own terms 
• Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University 
• Diverse corporate benefits with regard to employee health and staff events

We look forward to your application

If you would like to work in an open creative and helpful team we offer you the right environment here. We look forward to receiving your application with your salary expectations and availability.

Remote Work :

No

Employment Type :

Fulltime