R&D Scientist | Scientist Research & Development (m/w/d)
QUESTALPHA GmbH & Co. KG
Job Summary
As an R&D Scientist at QUESTALPHA, you will lead the development of high-risk medical devices, including Class III products containing Active Pharmaceutical Ingredients (APIs). Your daily responsibilities involve creating comprehensive development documentation, SOPs, and scientific reports according to ISO 13485 standards. You will oversee experimental studies and manage the transition of products from lab-scale pilot projects to full-scale internal and external production facilities. This role requires close collaboration with cross-functional teams such as Regulatory Affairs, Quality Management, and external CDMOs/CROs. This position is particularly attractive for professionals looking to work in a fast-growing, internationally oriented family business where they can actively shape product innovation in the life sciences and healthcare sectors. You will have the opportunity to manage complex sub-projects and influence the market through continuous trend monitoring and proactive product improvements.
Required Skills
Education
Master's degree in Biopharmaceutical Technology, Biotechnology, Medical Engineering, or a comparable field of study.
Experience
- Professional experience in the development of pharmaceutical or medical products within a regulated environment
- Experience in creating development documentation for medical devices according to ISO 13485
- Proven track record in coordinating collaborations with academic partners, industrial partners, and service providers such as CROs
- Experience in managing complex sub-projects and understanding business contexts
- Experience in Biologics, Material Science, or Bioconjugation is preferred
Languages
Additional
- The candidate must demonstrate a structured and independent working style with strong communication skills. Must be able to work full-time at the Eschenburg location.