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CMC Process Development Lead (m/f/d)

Remote EU, DE | Office - Ulm
Full-time
Permanent employee

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 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.