CMC Development Manager (mfd)

NVision Imaging Technologies; Ulm; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading biotech startup in Ulm, Germany is seeking a CMC Development Manager to lead innovative drug development programs. You will oversee product development, ensuring compliance with quality standards, while collaborating with multidisciplinary teams. The ideal candidate has a Master's or PhD, with at least 5 years of industry experience. This role offers a competitive compensation package, flexible working options, and the chance to contribute to impactful cancer treatments.

Leistungen

Attractive compensation package

30 vacation days

Annual health budget

Qualifikationen

• At least 5 years of experience in analytical chemistry, process development, or manufacturing within the pharmaceutical industry.
• Demonstrated expertise in CMC development including manufacturing process validation.
• Strong understanding of GMP, GLP, and ICH guidelines.

Aufgaben

• Lead process development activities including optimization and testing.
• Work closely with R&D on validation of analytical methods.
• Design stability studies and impurity profiling.

Kenntnisse

Analytical method development

Process development

Manufacturing

Quality compliance

Collaboration with teams

Ausbildung

MSc or PhD in chemistry or related field

Tools

UV/Vis

NMR

HPLC

GC

Jobbeschreibung

Overview

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.

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:

Daniel Sypli

Sr. Talent Acquisition Manager

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. 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 won't review applications or CVs sent via email. Unsolicited applications can be submitted here.

Additional

Employment Type: Full-Time

Experience: years

Vacancy: 1