Device Scientist Full-time NEW

Device Scientist (100%)

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high-quality products and services to help heal, cure disease and improve the quality of life.

Cilag AG is a successful international development and manufacturing facility in the pharmaceutical sector of Johnson & Johnson, located in Schaffhausen, Switzerland. At our Schaffhausen site, about 150 people work for the global Johnson&Johnson Innovative Medicine Research & Development organization developing innovative treatments that improve the health and lifestyles of people worldwide.

The Analytical Development organization in Schaffhausen provides highly specialized support for marketed products, fill-finish pilot plant activities for biotherapeutics, manufacturing analytics, and device characterization. We are offering an outstanding opportunity for a

The Device Methods Laboratory (DML) is a unique group as part of the Analytical Development (AD) organization in Schaffhausen within Johnson&Johnson 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 including the support of technology transfers as well as covering product life cycle management such as the handling and resolution of global product quality complaints. As a development lab within the global Research & Development organization which 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 for the development and functional characterization of primary containers, parenteral drug delivery systems and combination products used for the administration of biotherapeutic 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 an analytical subject matter expert during device investigations and handling of complaints and maintain close interaction with business stakeholders.

Responsibilities:

• Assume a leading role to advance the data insight-driven introduction and characterization of patient-focused parenteral drug delivery systems
• Shape the control strategy for combination products and coordinate operational activities in a GMP regulated environment
• Provide technical and scientific expertise to address and translate analytical needs and regulatory requirements into the development and implementation of combination products
• Lead and execute device investigations and the handling of customer complaints and provide hands-on expertise during non-conformance testing and troubleshooting
• Design experimental plans based on defined deliverables and self-dependently perform device testing activities related to the development, validation, and transfer of physical test methods for the release and stability of combination products in a GMP regulated environment
• Cultivate strong relationships and independently liaise with cross-functional teams and external partners and stakeholders and serve as a subject matter expert to ensure patient-centered design and development of parenteral drug delivery systems and combination products
• Translate industry and Health Authority guidelines and requirements into operational business
• Author global analytical documents to ensure highest quality of data
• Prepare device-specific granules for clinical and commercial submissions
• Effectively use your network within industry and academics to screen and evaluate new technologies

Profile:

For this position, we are looking for an experienced, flexible, and team-oriented person with excellent communication and negotiation skills, as well as the following technical skills:

• M.S. or Ph.D. with minimum 2 years of experience in life sciences, (bio-)engineering, analytical sciences, or pharmaceutical sciences
• Curious and entrepreneurial spirit driven
• Strong project coordination and management skills
• Broad scientific knowledge in Pharmaceutical or Analytical Sciences
• Committed to perform and thrive in a highly dynamic, fast-paced environment
• Motivated by achieving extraordinary goals creating cutting-edge products for our patients
• Excellence in organizational, analytical, and problem-solving skills, with attention to detail
• Good team player with excellent communication skills at all levels
• Fluent in English (oral and writing), German desired

Required Skills:

Preferred Skills: Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaborating, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression