CMC Development Manager (m/f/d)
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