Clinical Trial Lab Manager (m|f|d)

at  Miltenyi Biomedicine

Company Description
Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients’ lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.
Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.
Job Description

In the Clinical Trial Execution Service department, your role will support our trial processes and activities in line with our go-to-market 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 CAR-T/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 I-III 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 Master’s 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

• 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 I-III 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