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.

The Lab Vendor & Operations Manager is responsible for the selection, oversight and management of our central and speciality laboratory vendors. This role is essential to achieving the bioanalytical objectives (e.g. biomarker, PK/PD, immunogenicity) as part of our clinical development programs. The role ensures that all vendors meet our established standards for assay and data quality, efficiency and compliance in the timely execution of Phase 1-3 clinical trials worldwide in the areas of Cell and Gene Therapy and Medical Devices.

• Lab Vendor Management: You will be responsible for the identification, selection and oversight of central and special laboratories for our clinical trials in terms of quality, costs and capabilities. You will support our QA during lab qualification as SME, and execute the RFP process.
• Overseeing Deliverables: You will ensure that vendors meet or exceed expected timelines for test results, adhere to industry standards and regulations, You will escalate, support the solution of and communicate issues to all relevant stakeholders.
• Assay Development and Transfer, Lab Readiness: You will work closely with other Miltenyi teams to ensure that transferred assays and reference ranges are validated, verified and harmonized at our lab vendors. You ensure that labs are operationally ready as planned.
• Stakeholder Management: As First Point of Contact (FPOC) between Miltenyi and the laboratories, you will keep the internal trial teams and other stakeholders updated about the suppliers performance. You will participate in appropriate meetings.
• Quality Metrics and Continuous Improvement: You will frequently evaluate, track and report our lab supplier performance, cost efficiency and compliance, and identify and implement new strategies for process improvement and cost reduction.

• You possess a Master's degree or higher, ideally a PhD in biochemistry, biology, pharmacy, or a related field, along with several years of experience in a clinical laboratory, biotech, pharma, or CRO setting.
• A thorough understanding of the legal framework pertinent to the development of bioanalytical assays and the quality standards for laboratory data in clinical research (EU, USA) is crucial for this role. Experience in managing vendors, projects, and laboratory processes is preferred.
• You stand out with robust communication and negotiation skills, the ability to work under pressure, and dependability.
• You are fluent in German (C1) and business-proficient in English (B2).
• Your profile is complemented by high levels of accountability, extroversion, a team and action-oriented approach, problem-solving abilities, and skills in setting priorities.

What we offer

• Flexible and partially remote work: Enable time management on your terms
• Diversity: International teams and cross-border intercultural communication
• Room for creativity: It’s the most clever solution that we always strive for
• Health & Sport: We offer a wide range of corporate sports activities and health provision
• Miltenyi University: A clever mind never stops learning, take advantage of our inhouse Training Academy

We look forward to your application

If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.