Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Scientist, located in 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Scientist - Small Molecule Method Development will be responsible for end to end analytical development and lifecycle management of active pharmaceutical ingredients and pharmaceutical finished products. This individual will be responsible primarily for method development and qualification/validation including HPLC, UHPLC, GC, KF, etc., coordination of analytical method transfers and providing input for the preparation and updates of the regulatory filings. This role provides technical support of the analytical methods for products in various development phase and marketed products, to QC laboratories, Quality Assurance, Regulatory Affairs, and supervision to external partners. The candidate will support audits, regulatory submissions, and participate as group representative on project teams. She/he will work in a global environment in a matrix organization. Additional responsibilities include but are not limited to the following:
- Design and execute scientific experiments especially in the separation sciences
- Maintain a lab presence and will be actively and personally involved in lab work
- Ensure the proper and timely preparation of technical reports including protocols and final reports through use of electronic laboratory notebook systems and electronic document management systems
- Participate in establishing priorities, checkpoints, and time frames for experimental work in support of team objectives
- Advise team leaders of resources needed to accomplish tasks
- Follow established operating procedures and safety regulations adhering to company work standards
- Bachelor's degree in a life science with at least 6 years of related scientific experience OR a Master's degree in a life science with at least 2 years related scientific experience OR a PhD. in a life science is required
- Technical knowledge of analytical chemistry and chromatographic proficiency, especially HPLC and GC are required
- Experience in UHPLC is preferred
- A working knowledge of characterization techniques (MS, NMR, IR, NIR), KF and dissolution are preferred
- Comprehensive knowledge of global regulatory and guidance documents (e.g. ICH) as well as analytical method validation requirements are preferred
- Experience working in a cGMP regulated laboratory is preferred
- Knowledge of chromatographic software such as Waters Empower is preferred
- Working knowledge of Waters and/or Agilent chromatographic instruments is preferred
- Working knowledge of electronic laboratory notebook systems is preferred
United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function