CMC Development Manager (m / f / d)

NVision Imaging Technologies; Baden-Württemberg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biotech startup in Germany is seeking a CMC Development Manager to advance an innovative drug development program. The candidate will lead process development, manage analytical methods validation, and ensure compliance with quality standards. This position offers a competitive salary, stock options, and the flexibility of remote or hybrid work. Ideal candidates will have an MSc or PhD in a relevant field and significant experience in the pharmaceutical industry. Join us in making impactful advancements in cancer treatment!

Leistungen

Attractive compensation package

30 vacation days

Flexible working hours

Annual health budget

Relocation support

Qualifikationen

• At least 5 years of experience in analytical chemistry or process development.
• Demonstrated expertise in CMC development and technology transfer.
• Strong background in analytical method development and validation preferred.

Aufgaben

• Lead process development activities and manufacturing process optimisation.
• Work with R&D to validate analytical methods.
• Coordinate interactions with third-party CDMOs.

Kenntnisse

Analytical chemistry

Process development

Manufacturing within pharmaceutical industry

Analytical method development

GMP and GLP compliance

Ausbildung

MSc or PhD in chemistry, pharmaceutical science, or chemical engineering

Tools

NMR

HPLC

GC

Jobbeschreibung

Your mission

As a CMC Development Manager (m / f / d), you will be a key leader in advancing our innovative drug development program. You will take ownership of the development of our products, from analytical method development and validation to drug substance and drug product manufacturing processes optimization. Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, scalability, and regulatory compliance.

Key responsibilities

• Lead process development activities, including manufacturing process optimisation, material qualification, and compatibility testing internally and with contractors
• Work closely with R&D to develop and then manage validation of analytical methods for identity, purity, and impurities, utilizing techniques such as UV–Vis, NMR, HPLC, GC, and Raman internally or with contractors
• Design stability studies and impurity profiling to ensure processes are reliable and fit for purpose.
• Drive drug product development activities, including formulation and sterile process design
• Play a key role in coordinating interactions with third-party CDMOs to support outsourced activities.
• Support scale-up and technology transfer to clinical manufacturing sites.
• Prepare and review CMC documentation, including experimental reports, protocols, SOPs, and eCTD sections.
• Work across development, quality, regulatory, and supply chain teams to keep projects aligned and on track.

Your profile

• MSc or PhD in chemistry, pharmaceutical science, chemical engineering, or a related field
• At least 5 years of experience in analytical chemistry, process development, or manufacturing within the pharmaceutical or biotech industry
• Demonstrated expertise in CMC development, including manufacturing process validation and technology transfer
• Strong background in analytical method development and validation (NMR, GC, HPLC) preferred
• Strong understanding of and experience working in an environment compliant with GMP, GLP, and ICH guidelines
• Very good written and spoken English skills

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 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

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 : [e-mail]

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.