Specialist* Biomarker Operations
- Work experience
- Project Management, Product Management
- Research, development, teaching
Become a member of the BioNTech Family!
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people´s lives.
Specialist* Biomarker / Biosample Operations
- Plans, coordinates and oversees all operational activities to manage the lifecycle of biomarker samples for assigned programs and clinical trials in alignment with the program biomarker plan and liaison with the program Translational Sciences lead
- Diligently documents and tracks biomarker samples collected in clinical trials and release and coordinate samples for further analyses as required
- Organizes sample retrieval and shipments
- Establishes and ensures accurate tracking and reporting of biomarker samples and data metrics
- Facilitates cross-functional interactions and creates awareness for interdependencies of trial- and program-wide biosampling activities
- Builds and maintains efficient biomarker sample analysis & data delivery processes
- Day-to-day operational routine management of biomarker vendors, including monitoring and invoicing
- Supports delivery of relevant (Clinical/Biomarker) Program Sub Team goals and milestones
- Contributes (reviewing, authoring) to relevant Biomarker documents such as e.g. Biomarker Manuals, Lab Manuals
- Consults and supports Translational Sciences Leads in identifying gaps and needs for process improvements. Actively engage (lead or support) as requested in the implementation of new processes or process improvements to optimize operational efficiency incl. preparation and revision of SOPs and guidance documents.
- Ensure adherence to current regulations and standards (IHC/GCP, SOPs) related to sample handling and data privacy.
What you have to offer.
- Vocational training (biology/chemistry/molecular biology) or comparable studies in the natural sciences (Bachelor)
- Experienced in working within interdisciplinary cross-functional program teams in a matrix environment
- Hands-on experience in GxP (GLP, GMP, GCP) regulated laboratory environment
- Strong communication, organization and coordination skills
- Experience in CRO/vendor management
- Excellent, targeted communication and expert stakeholder management
- Project Management experience
- Proficient in the use of MS Office software
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Reece Freeman will be happy to answer them on + 49 (0) 6131-9084-1211 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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