Sr Sci Biotherapeutics RD
J&J Family of Companies
Senior Scientist (m/f)
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 within the global Research & Development organization that is embedded in the GMP environment we strive for innovative solutions for the administration of biotherapeutic products and shape new visions 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 in the development and functional characterization of combinations products, parenteral drug delivery systems and primary containers used for the administration of pharmaceutical products across numerous therapeutic areas such as oncology, immunology, and neuroscience in accordance with cGMP. In your role you provide technical, scientific and project management expertise as well as lead and execute critical analytical phases in the combination product development process. In addition, you serve as analytical subject matter expert during device investigations and handling of device 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 the development and Life Cycle Management of combination products
+ Assume a leading role to advance the data insight-driven characterization of patient-focused parenteral drug delivery systems
+ Lead and execute device investigations and the handling of customer device complaints and provide hands-on expertise during non-conformance testing and troubleshooting
+ Design experimental plans based on defined deliverables and conduct the development, validation, and transfer of physical test methods for the release and stability of combination products in a GMP regulated environment
+ Cultivate strong relationship and independently liaise with cross-functional teams, external partners and stakeholders
+ Translate industry and Health Authority guidelines and requirements into the operational business
+ 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 interest
**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
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