.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 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, 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 a focus on late phase and support of marketed products.
Additionally, 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 relationships and independently liaise with cross-functional teams and external partners and stakeholders.Author scientific and analytical documents to ensure the 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