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Cmc project manager (m/f/d)

Ulm
NVision Imaging Technologies
Projektmanager
Inserat online seit: 1 Oktober
Beschreibung

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 Your profile Academic degree (e.g., MSc) in pharmacy, chemistry or comparable > 3 years experience in CMC / pharmaceutical development with at least > 1 year experience in managing development projects in international cross-functional organizations operating in a highly regulated and safety-critical environment Comfortable with a range of project management methodologies (sequential/ waterfall, agile etc.) Ability to manage internal and external stakeholders, drive multiple competing priorities, escalate risks and facilitate decision making by provision of facts and figures Strong written and oral communication skills Strong analytical and quantitative problem-solving skills Fluent English skills, fluent German skills are a plus Why us? Competitive compensation, based on base salary and company shares Flexible working hours and a hybrid work model (no relocation to Ulm needed, but regular on-site visits are necessary) Annual health budget (Allianz bKV) Key role in a highly advanced and fast-growing startup company Ample opportunity for personal initiatives, openness to new ideas and room for considerable personal impact Impactful product promoting better understanding and treatment of disease International and dynamic team, from over 20 different nationalities Enjoyable work atmosphere with an open-door and open communication mentality Permanent employment contract 30 vacation days contact information Any questions? Please contact: Daniel Sypli Talent Acquisition Manager mail: careers@nvision-imaging.com 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. _ Please note that, for data privacy reasons, we'll not review applications or CVs sent via email. Unsolicited applications can be submitted here .

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