Sr Scientist Biotherapeutics RD

Design experimental plans and serve as the analytical development expert on combination product testing, test method development and validation. Assume a leading role to advance the data insight-driven characterization of patient-focused parenteral drug delivery systems. Translate industry and international regulatory standards into the operational business to support the development and Life Cycle Management of combination products. Lead and execute device investigations and the handling of customer complaints and provide hands-on expertise during troubleshooting. Ensure best scientific and GMP standards. Establish and cultivate strong relationships and independently liaise with cross-functional teams, external partners and stakeholders. Support the preparation and review of technical reports and global regulatory submissions. Evaluate new and innovative technologies, methodologies and modalities to support science-based advancements.

The Device Methods Laboratory (DML) is a unique group within Johnson and Johnson Innovative Medicine responsible for the end-to-end development and testing of combination products, drug delivery systems and primary containers. Our wide range of responsibilities spans across early and late stages of clinical development including the support of technology transfers as well as cover product life cycle management such as the handling and resolution of global product quality device complaints. As a development lab that is embedded in the GMP environment within the global Research & Development organization we strive for innovative solutions in drug delivery and shape new visions for the development of medicines of tomorrow.

• Self-employed and entrepreneurial working style

• Curiosity and drive to deep dive into scientific questions

• Excellence in analytical and problem-solving skills, with attention to detail

• Ability to make strategic recommendations

• Strong project coordination and management skills

• Committed to perform and thrive in a highly dynamic, fast-paced environment

• Motivated by achieving extraordinary goals creating cutting-edge products for our patients

• Team player with excellent communication skills at all levels

• Strong knowledge of GMP

• Fluent in English (oral and writing), German desired

• PhD in Analytical Chemistry, Biochemistry, or related scientific discipline with minimum 2 years of experience in the pharmaceutical or biotech industry