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, primary containers, and secondary packaging. Our wide range of responsibilities spans across early and late stages of clinical development, support of technology transfers as well as cover product life cycle management such as the handling and resolution of global product quality complaints. As a development lab of the global Research & Development organization which is embedded in the GMP environment we strive for innovative solutions for the administration of biotherapeutic products to continuously advance in drug delivery system development and testing.

Working in an international, dynamic, and diverse team of people you are a key contributor for the functional characterization of primary containers, parenteral drug delivery systems and combination products for biotherapeutic products across numerous therapeutic areas such as oncology, immunology and neuroscience. Your scientific dedication and agility to work in a GMP-regulated environment are critical to ensure the development of robust and compliant applications and approaches. In your role you provide technical, scientific and project management expertise as well as lead and execute critical analytical phases of the combination product development process with focus on late phase and support of marketed products. In addition, you serve as analytical subject matter expert during device investigations and handling of complaints and maintain close interaction with business stakeholders.

Your Responsibilities:

• Provide technical and scientific expertise to address and translate analytical needs and regulatory requirements to support LCM projects of parenteral drug delivery systems and combination products
• Assume a leading role to advance the data insight-driven characterization of patient-focused parenteral drug delivery systems
• Design experimental plans based on defined deliverables and support device testing activities to support the development, validation, and transfer of physical test methods, design verification and process validation in a GMP regulated environment
• Lead and execute device investigations and the handling of customer complaints and provide hands-on expertise during non-conformance testing and troubleshooting
• Cultivate strong relationship and independently liaise with cross-functional teams and external partners and stakeholders
• Author scientific and analytical documents to ensure highest quality of data
• Support regulatory submissions
• Effectively use your network within industry and academics to screen and evaluate new technologies in the area of expertise
• Work in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleagues

Qualifications

Your Profile:

For this position we are looking for a scientifically minded, flexible, and team-oriented person with the following skills:

• 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
• Good team player with excellent communication skills at all levels
• Fluent in English (oral and writing), German desired
• PhD with minimum 2 years of experience in the pharmaceutical or biotech industry