Your mission
We are seeking a CMC Project Manager (m/f/d) to act as a key member of the clinical program. You will steer the development of our clinical polarizer, consumables, and the hyperpolarized drug product in close collaboration with internal teams (R&D, Q&RA, Operations) and external partners (CDMOs). Your expertise in CMC process management and a solution-oriented mindset are crucial for successfully navigating complex technical dependencies, timelines, and quality standards.
Your responsibilities shall include but may not be limited to the following:
Lead cross-functional project teams to develop products or components being part of the hyperpolarization technology serving the needs of our customers
Support the evaluation of new projects and the definition of project scope and goals in alignment with the Working Group Lead to allow achievement of program and business goals
Plan, coordinate, monitor and manage assigned projects to safeguard their quality and progress within time and budget from initiation through delivery.
Ensure that development activities and deliverables meet applicable requirements and timelines to support submissions and clinical studies
Forward-looking identification and assessment of project risks and definition of mitigation/ contingency strategies
Drive collaboration, an effective communication and transparency within the working group and/or project core team as well as with other involved stakeholders
Act as single point of contact for external partners (subcontractors, consultants, development partners) and foster sustainable relationships
Take over project member / work package owner role, as required
Support the Head of Program Management in defining, implementing and living project management best practices and methodologies across the company
Support the development and implementation of processes, services or tools supporting the successful delivery of systems and consumables
About us
NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.
We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology and more. Our company brings together expertise in physics, chemistry, engineering and medicine, and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.
NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.
We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.
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Please note that, for data privacy reasons, we'll not review applications or CVs sent via email. Unsolicited applications can be submitted here.
