As a CMC Process Development Specialist (m/f/d), you will play a crucial role in developing and validating manufacturing processes and reagent kits. Your focus will be on ensuring these processes are robust, scalable, and compliant with regulatory requirements. You will work closely with cross-functional teams and oversee partnerships with Contract Development & Manufacturing Organisations (CDMOs) to optimise workflows, facilitate technology transfer, and maintain high-quality standards. Additionally, you will prepare and review CMC documentation to support regulatory submissions.

Key Responsibilities:

CDMO & Process Development:

• Manage the scale-up and optimisation of manufacturing workflows to meet clinical and regulatory requirements.

• Oversee and coordinate CDMO partnerships, ensuring efficient development, validation, and technology transfer of manufacturing processes.

• Evaluate and monitor third-party performance to maintain compliance with regulatory and quality standards.

Collaboration & Technical Support:

• Work cross-functionally with R&D, product development, and quality assurance teams to enhance process efficiency and ensure regulatory compliance.

• Provide technical expertise in process development, impurity analysis, toxicology studies and quality control.

• Support troubleshooting and resolution of manufacturing and analytical challenges.

Documentation & Compliance:

• Prepare, review, and maintain CMC-related documents, including reports, protocols, SOPs, and eCTD modules.

• Ensure accurate and complete documentation of process development activities for regulatory submissions.

• Adhere to GMP, GLP, and ICH guidelines while ensuring data integrity and compliance with global regulatory standards.

• 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.

• Attractive compensation package, including a competitive base salary and stock options

• Impactful product promoting better understanding and treatment of cancer

• International team, from over 20 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

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

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.