Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist within the Drug Product Development group. This position can be located in Malvern, PA, Spring House, PA, or Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Biotherapeutics department is offering an excellent opportunity for a Scientist. The Scientist, as part of the Drug Product Development group, will be responsible for supporting combination product development involving parenteral injection devices delivering biologics and peptides (mAbs, Gene therapies, Cell therapies etc.) and will work closely with the Primary Container and Device group. This position has an important role in the design, testing and technology transfer of state-of-the-art platform injection devices. This individual will lead studies and manage activities related to establishing product-process relationships for these biologic-delivery device combination products. This will include the development and optimization of the technical operations associated with these products. In this capacity, the Scientist will serve as a technical team lead and working technical member of new product development programs.
Manage and perform study design and execution activities to determine and characterize process parameters associated with preparation of biologic drug and combination products. Studies may include formulation development, process development (fill-finish), combination products/device functionality and assembly, and related product performance and stability evaluations.
Partner with product and process development teams to ensure combination product design incorporates good Design for Manufacturability principals and ultimately meets established product/process specifications for the drug product.
Foster perspectives and needs from cross functional partners during the development process
Lead design transfer activities for biologic-device combination products
Perform technical analysis of the project data, including trending of data
Author technical reports and make presentations of technical data
Follow general laboratory safety procedures, as related to biologically-derived materials
A minimum of 9 years of related laboratory experience with a Bachelor’s degree in Engineering (preferably Mechanical, Process, and Bio-Medical) or a minimum of 6 years of related laboratory experience with a Master’s degree in Engineering is required.
Pharmaceutical and/or Biotechnology experience is preferred.
Experience with formulation, parenteral injection delivery devices, and fill/finish process development for therapeutic biologic drug products (mAbs, cell therapies, gene therapies etc.) is preferred.
Experiences with product and process development practices such as Design of Experiments, statistical analyses, process excellence tools, CQA’s/CPP’s, capability analyses, and design transfer are preferred.
Working knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements preferred.
Experience with characterization of biological molecules is preferred.
Project management skills, such as developing and managing project plans, are preferred.
Must have excellent strong written and verbal communication skills.
The ability to collaborate in a matrixed environment is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)