CMC Process Development Lead-Hybrid with Stock Options

Your mission As a CMC Process Development Lead (m/f/d), you will lead the development and validation of manufacturing processes for starting materials, drug products, and reagent kits. Your role will focus on establishing robust and scalable processes suitable for clinical use. You will work closely with internal teams and Contract Development & Manufacturing Organisations (CDMOs) to support process scale-up, analytical method development and validation, fill-and-finish activities, and clinical manufacturing site readiness. You will also contribute to the preparation of CMC documentation for regulatory submissions. Your mission As a CMC Process Development Lead (m/f/d), you will lead the development and validation of manufacturing processes for starting materials, drug products, and reagent kits. Your role will focus on establishing robust and scalable processes suitable for clinical use. You will work closely with internal teams and Contract Development & Manufacturing Organisations (CDMOs) to support process scale-up, analytical method development and validation, fill-and-finish activities, and clinical manufacturing site readiness. You will also contribute to the preparation of CMC documentation for regulatory submissions. Key Responsibilities CDMO & Process Development: Manage the development, optimisation, and scale-up of manufacturing processes for starting material and drug products. Work closely with CDMOs on process development, technology transfer, and validation activities. Oversee external partners to ensure manufacturing processes meet quality and regulatory requirements. Analytical Development Develop and validate analytical methods for process monitoring, release testing, and stability studies. Collaborate with internal teams and CDMOs to ensure analytical methods are suitable for clinical use. Sterilisation & Fill and Finish: Define sterilisation strategies for excipients and process materials, including sterile filtration. Drive the development and validation of fill-and-finish processes for clinical manufacturing. Clinical Site Support & Documentation: Support the technical set-up of clinical manufacturing and testing sites. Prepare and review CMC documentation, including protocols, reports, and regulatory submission content, in line with GMP and ICH guidelines Your profile MSc or PhD in pharmaceutical sciences, chemical engineering, or a related field. At least three years of experience in process development, manufacturing, or a related role within the pharmaceutical or biotech industry. Demonstrated expertise in CMC development, technology transfer, and manufacturing process validation. Strong scientific skills, with a passion for experimental work in innovative drug development. Experience managing CDMO partnerships and working with external manufacturing partners. A strong understanding of GMP, GLP, ICH guidelines, and regulatory requirements for pharmaceutical product development. Excellent problem-solving skills and the ability to collaborate effectively within a cross-functional team in a dynamic environment. Strong technical writing skills, with experience preparing CMC documentation and regulatory submissions. Experience in contrast agents, radiopharmaceuticals, or drug-device combinations is advantageous. Why us? Attractive compensation package, including a competitive base salary and stock options Impactful product promoting better understanding and treatment of cancer International team, from over 30 different nationalities Positive work environment with open communication and a collaborative mindset Remote or Hybrid working model possible Indefinite employment contract 30 vacation days Flexible working hours Annual health budget (Allianz bKV) EGYM Wellpass Relocation support 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 innovating quantum technology with a unique approach - leveraging organic molecules to change lives for the better. Our platform spans from quantum signal enhancement that enables metabolic imaging today to quantum computing that could transform drug discovery tomorrow. Headquartered in Ulm, Germany, and backed by leading investors from the United States and Europe, we are now entering a phase of global commercialization and expansion. With our POLARIS product line, we are extending the capabilities of standard MRIs to enable real-time metabolic imaging, transforming how diseases are detected, understood, and treated. Our work sits at the intersection of physics, engineering, chemistry, and medicine - translating cutting-edge science into clinical reality. We collaborate with leading academic and clinical partners worldwide, including Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Technical University of Munich, and the University of Cambridge. At NVision, we believe transformative innovation happens when talented people from different disciplines work together toward a shared, meaningful goal. We are a global, multidisciplinary team of nearly 150 employees from more than 30 nationalities, driven by curiosity, rigor, and a commitment to solving complex challenges. Here, ideas are valued, ownership is real, and collaboration spans functions, disciplines, and borders. If you are motivated by impact, thrive in dynamic environments, and want to contribute to something fundamentally new, NVision offers the opportunity to grow while building technology that changes lives. Please note that, for data privacy reasons, we'll not review applications or CVs sent via email. Unsolicited applications can be submitted here . J-18808-Ljbffr