Senior/Principal Scientist - Drug Substance Dev NCE
Hybrid · Ingelheim am Rhein, Rheinland-Pfalz, Germany
Job Summary
Senior/Principal Scientist in Drug Substance Development NCE, based in Ingelheim, Germany, with a hybrid work setup (approx. 3 days on site) and part-time eligibility (80%). Lead analytical development projects (non-GMP and GMP) for drug substances for clinical trials and market, support regulatory submission documentation, and collaborate across global cross-functional teams. The role includes scientific leadership for complex initiatives, developing innovative analytical solutions, and ensuring compliance with regulatory and EHS standards across development phases. Requirements include a PhD or Master’s degree in analytical sciences or related field, strong expertise in analytical method development, knowledge of cGMP/regulatory requirements, excellent organizational and problem-solving skills, and fluency in German and English. Principal Scientist additional duties emphasize strategic knowledge generation, guidelines, publications, patents, and leading teams in global projects.
Required Qualifications
- PhD (e.g., PhD, MD) or Master’s degree (e.g., MSc) with a focus on analytical sciences or a related field with several years of relevant professional experience
- Strong scientific expertise in analytical method development
- Knowledge of cGMP regulations and regulatory requirements for drug substance registration is advantageous
- Strong organizational skills with the ability to manage changing priorities and multiple tasks effectively
- Excellent problem-solving skills with a solution-oriented mindset
- Fluent in both German and English (written and spoken)
- Additional requirements for Principal Scientist: PhD (e.g., PhD, MD) with several years of relevant professional experience or Master’s degree (e.g., MSc) with longterm relevant professional experience
- Extensive expertise in analytical method development and validation for pharmaceutical drug substances for clinical trials and market
- In-depth experience in cGMP regulations and regulatory requirements for drug substance registrations clinical trials and market
- Experience in leading teams or strong track record to collaborate proactively in global project teams
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