Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Associate Scientist, located in Malvern, PA.
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 candidate will be responsible for the performance and improvement of our current laboratory practices. The candidate will provide routine testing support and development of a variety of Separation and Purity methods. The candidate will also provide technical project support, lead projects, review lab documentation, present data to technical teams, and mentor other scientific staff. The individual will be expected to document GXP laboratory activities in a compliant manner, prepare reports, author SOPs and contribute to regulatory filings. The candidate must be able to work independently and serve as a lead in the laboratory. The candidate must address complex problems through the analysis of data requiring strong process knowledge and in-depth evaluation of multiple variables. Additional responsibilities include but are not limited to:
Perform laboratory testing and record data per GXPs, SOPs, and Protocols
Author and revise SOPs and Protocols
Perform data review and present results to different teams
Provide training to scientific staff
Participate in method development/validation, Pharmacy Manual, and method transfers
Serve as representative on cross-functional teams
Perform other duties as designated by laboratory management
B.S. or equivalent in Chemistry, Biochemistry or related discipline is required with a minimum of 6 years of related laboratory experience or a M.S. with 5 years of related laboratory experience.
Experience in 3 or more of the following areas is required (SE-HPLC, cSDS or CE-SDS, ELISA, cIEF, CIEX, RP-HPLC, HILIC, FRET and particle testing)
Experience in analytical, method development, QC or relative industry labs is required
Solid understanding of large molecule testing is required
Demonstrated experience with programming, database structures, and forecasting are preferred
Knowledge of cGMP regulations, basic understanding of data trending, use of electronic notebook and Empower are preferred
A broad understanding of purification and formulation processes is preferred
Technical writing experience (SOPs and Protocols) is preferred
This position may require up to 5% domestic or international travel
Janssen Research & Development, LLC. (6084)