A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
You take over project responsibility as analytical development expert in CMC teams for new chemical entities (NCE) from phase 0 to clinical phase III. You work within a GMP environment, assess the quality of drug substance and drug product intended for use in clinical trials and act as “Head of Quality Control” according to German and EU legislation. Furthermore you develop quality relevant specifications for drug substances and products, be responsible for structure elucidation of impurities, setup and monitoring of stability studies. You coordinate and drive the scientific strategy for the analytical method development of new drug substances and drug products. Application and continuous development of the QbD concept during the product design phase as described in ICH Q8 and ICH Q11 as overarching paradigm of the product lifecycle. You assure a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and how they are impacted by the manufacturing process. You cooperate within interdisciplinary and international teams, especially with other functions of chemical and pharmaceutical development and global pharma operations. You collaborate closely with contract manufacturing organizations (CMOs): Evaluate capabilities of CMOs and manage projects in cooperation with CMOs. Review and contribute to regulatory documents intended for submission to Health Authorities. You ensure launch readiness for all analytical activities including transfer of methods to commercial organizations.
Who you are:
- Scientific degree (pharmacy, chemistry or similar) with an emphasis on analytical science preferably with PhD
- Broad expertise in analytical technologies and their field of application for testing of NCEs (drug substance and drug product)
- Ideally 2-3 years of experience in the pharmaceutical industry
- Demonstrated knowledge in application of ICH Q8, Q9, Q10, and Q11 concepts in Pharmaceutical Development
- Knowledge of current quality and regulatory requirements relevant for NCE development
- Very good communication skills, both written and oral in English and German
- Excellent organizational skills, reliable teamplayer
- Highly motivated and results-orientated, willingness to take on responsibility
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com