Job Summary
The Device Methods Laboratory (DML) is a unique group within Johnson & 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 and product life cycle management such as handling and resolving global product quality device complaints. 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.
As a key contributor in an international, dynamic, and diverse team, you will develop and functionally characterize combination products, parenteral drug delivery systems, and primary containers across therapeutic areas such as oncology, immunology, and neuroscience. You will provide technical, scientific, and project‑management expertise and lead critical analytical phases in the combination product development process, serve as an analytical subject‑matter expert during device complaint handling and investigations, and maintain close interaction with business stakeholders.
Responsibilities
* 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 data, insight‑driven characterization of patient‑focused parenteral drug delivery systems.
* Translate industry and international regulatory standards into operational business processes to support development and life‑cycle management of combination products.
* Lead and execute device investigations and handle customer complaints, providing hands‑on expertise during troubleshooting.
* Ensure best scientific and GMP standards.
* Establish and cultivate strong relationships, independently liaising with cross‑functional teams, external partners, and stakeholders.
* Support preparation and review of technical reports and global regulatory submissions.
* Evaluate new and innovative technologies, methodologies, and modalities to support science‑based advancements.
Profile
* Self‑employed and entrepreneurial working style.
* Curiosity and drive to deeply 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.
* Commitment to perform and thrive in a highly dynamic, fast‑paced environment.
* Motivated by achieving extraordinary goals and creating cutting‑edge products for patients.
* Team player with excellent communication skills at all levels.
* Strong knowledge of GMP.
* Fluent in English (oral and writing); German desired.
* Ph.D. in Analytical Chemistry, Biochemistry, or a related scientific discipline with a minimum of 2 years of experience in the pharmaceutical or biotech industry.
Required and Preferred Skills
* Analytical reasoning.
* Biochemistry, Chemistry, Manufacturing, and Control (CMC).
* Coaching.
* Consulting.
* Critical thinking.
* Drug discovery and development.
* Emerging technologies.
* Molecular diagnostics.
* Pharmacogenetics.
* Pharmacovigilance.
* Process improvements.
* Quality assurance (QA).
* Relationship building.
* Research documents.
* Scientific research.
* Technologically savvy.
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