Your mission
We are seeking a CMC Technology Transfer Specialist (m/f/d) to lead the implementation of the drug product manufacturing process and technology at clinical trial locations. In this role, you will be responsible for ensuring that investigational products are successfully introduced and integrated into clinical environments. You will coordinate the preparation of all necessary technical documentation and facilitate knowledge transfer. Your focus will be on enabling the seamless adoption of new processes and technologies at hospitals and other clinical facilities, ensuring compliance with regulatory and quality standards throughout the technology transfer process.
Key Responsibilities:
Support cross-functional teams to ensure all requirements are fulfilled before transferring processes to clinical trial sites.
Prepare and maintain documentation, including technology transfer packages, validation plans, risk assessments, and technical reports.
Oversee clinical site set-up and validation activities, ensuring protocols and reports meet regulatory and quality expectations and project timelines.
Play a key role in coordinating interactions with third-party CDMOs to support outsourced activities.
Manage quality-related activities (e.g. deviations, change controls, self-inspections) in line with internal policies and regulatory standards.
Assist in resolving manufacturing and analytical issues encountered at clinical trial sites.
Coordinate with internal teams and clinical site partners to align deliverables and timelines.
contact information
Join us in making a difference! Submit your application to be considered for this exciting opportunity.
Any questions? Please contact:
Emilija Stojanovska
Sr. 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.
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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.
