CMC Development Manager (m/f/d)

NVision.com

Hybrid

Remote Germany, Ulm

Full Time

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.
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
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:
Daniel Sypli
Sr. Talent Acquisition Manager
mail: careers@nvision-imaging.com