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 Senior Associate Scientist will be responsible for several activities to support the Reference Material (RM) and Critical Reagents (CR) program. Responsibilities include but not limited to serving as the point of contact to contractors and customer groups (site QC labs, AD labs, and in-country testing labs), coordinating preparation of reference standards and critical reagents as required by project need or inventory, reviewing and managing of inventories by approval of requests from customers, as well as coordinating qualification and requalification of standards and issuing the appropriate documentation. Responsibilities include but are not limited to:
- Maintaining qualification and re-qualification schedules for RM and CR, and work with QC sites to obtain the data necessary to prepare qualification and requalification documents and issue Certificate of Analysis
- Work with QC sites and statisticians to compile trending data as appropriate for large molecule reference materials and critical reagents
- Write SOPs, Specifications and Protocols to support all projects and programs
- Prepare the appropriate sections for regulatory filings and support inspections and audits
BS with at least 5 years experience OR MS with at least 3 years experience in Chemistry, Biochemistry or related discipline is required
Solid understanding of release and stability testing of large molecules is required
Large Molecule experience with any of the following: HPLC, ELISA, Bioassay, Capillary Electrophoresis, Characterization and cIEF is preferred
Knowledge of cGMP regulations, basic understanding of data trending and experience with process excellence methodology is preferred
Excellent communication skills (written, oral and presentation) and the ability to work in a cross functional environment are required
Strong technical writing experience (SOPs, Protocols, and Qualification Reports) is required
Regulatory writing experience (INDs, NDAs, BLAs) is preferred
Janssen Research & Development, LLC. (6084)Job Function