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 leadership, performance and improvement of our current laboratory practices. The candidate will provide routine testing support and co-qualification activities of Separation and ELISA methods using a variety of analytical techniques. The candidate will lead technical project support, projects, review lab documentation and independently interpret data, present data to technical teams and mentor other scientific staff. The candidate will be expected to contribute key elements of strategic development for projects within the group. The individual will be expected to document GXP laboratory activities in a compliant manner, prepare reports, author SOPs, contribute to regulatory filings and participate or lead laboratory investigations. The candidate must be able to work independently and serve as a lead in the laboratory and present unsolicited ideas to team leaders /management. Problems are complex, with the analysis of information or data requiring strong process knowledge and in-depth evaluation of multiple variables.
Responsibilities include but are not limited to:
Initiates an perform laboratory testing and record data according to GxPs, SOPs, and Protocols
Author and revise SOPs and Protocols
Perform GXP laboratory related investigations
Perform data review
Correct issues that may not be immediately evident, using existing or new processes
Provide training to scientific staff
Contribute to database development and suggest improvements to systems
Lead method co-validations and method transfers
Lead and 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 at least 8 years of related laboratory experience OR a M.S. with at least 5 years of related laboratory experience is required
- Experience in analytical, QC or relative industry labs with solid understanding of large molecule testing is required
- Experience in one or more of the following: SE-HPLC, cSDS, cIEF, or ELISA techniques is required
- Knowledge of cGMP regulations, basic understanding of data trending and use of electronic notebook and Empower is preferred
- Excellent communication skills (written and oral) and the ability to work in a cross functional environment are required
- Technical writing experience (SOPs and Protocols) is required
- Previous project leadership experience is required
- This position may require up to 5% domestic or international travel
Janssen Research & Development, LLC. (6084)Job Function