Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Scientist, located in Malvern, PA.
The 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:
- Work with RMCR team to execute routine fill finish of RMs and CRs onsite.
- 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
- Perform analytical testing as needed as part of reagent preparation and qualification.
- Follow general laboratory safety procedures
- A minimum of a Bachelors degree with 2-4 years of experience OR MS with 1-3 years of 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, cSDS, cIEF and Characterization 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), attention to detail and the ability to work in a cross functional environment are required
- Strong technical writing experience (SOPs, Protocols, and Qualification Reports) 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-Pennsylvania-Malvern-200 Great Valley Parkway
Janssen Research & Development, LLC (6084)