Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Schaffhausen, SwitzerlandJob Description:
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.
Working in an international, dynamic and diverse team of people you are a key contributor in the development and functional characterization of combination products, parenteral drug delivery systems and primary containers across numerous therapeutic areas such as oncology, immunology, and neuroscience. 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 complaint handling and investigations and maintain close interaction with business stakeholders.
Your 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 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
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
- 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
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy