CMC Process Development Lead; m​/f​/d

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.

• 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.

• 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.

• Define sterilisation strategies for excipients and process materials, including sterile filtration.
• Drive the development and validation of fill‑and‑finish processes for clinical manufacturing.

• 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.

• 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 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.

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:

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