- Catalent Pharma Solutions (Baltimore, MD)
- …molecular assays (ddPCR, qPCR, ELISA etc.) cell-based assays (infectivity, potency etc.), separation assays ( HPLC , CE -SDS, etc. ) is a plus. + Experienced in all ... aspects of method lifecycle support and regulatory strategy development, with preferred experience in writing or contributing to IND and BLA submissions to support regulatory milestones. + Proficient in the operations of a computer with MS Office, specifically… more
- Sanofi Group (Framingham, MA)
- …+ Experience with analytical and biophysical characterization techniques such as HPLC , HIAC, MFI, CE -SDS, cIEF, and various spectroscopy methods. ... religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional… more
- ThermoFisher Scientific (Boston, MA)
- …and FDA guidelines is highly desired. + Proficiency in analytical techniques, such as HPLC , CE , iCIEF, LC-MS, Titer, SoloVPE, and impurity methods. + Prior ... experience with reference material qualification and inventory management is a plus. + Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus. + Familiarity with GMP, GLP and regulatory guidance such as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for pre-pivotal (Phase I/II) biologic molecules. + Develop and execute analytical methods (using HPLC , CE , iCIEF, LC-MS, _etc_ .) to be used for molecule ... characterization and/or release testing. Author associated method development reports, test procedures, qualification protocols and reports. + Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …scientific presentations or reports. Develop and validate in-process analytical methods (eg, HPLC , CE , SDS-PAGE) to monitor critical quality attributes of ... biologics during manufacturing, ensuring regulatory compliance and consistency; Independently design and execute experiments, reporting results in a timely manner. Build and maintain relationships with vendors and assist with technical aspects of vendor… more
- Astrix Technology (Chicago, IL)
- …in protein chemistry and analytical troubleshooting. **Technical Skills:** + Proficient with HPLC , SDS-PAGE, ELISA, CE , bioassays, and compendial methods. + ... Experience with regulatory filings and inspection prep (eg, PAI). **Additional Info:** + Office/lab split; some travel may be required. + Fast-paced environment; must meet tight deadlines. This job description is a complete list of all desired skills but not… more
- Astellas Pharma (South San Francisco, CA)
- …+ Extensive experience in separation technologies including multiple modes for HPLC and Mass Spectrometry. + Success designing experiments, analyzing data and ... making decisions based on results from biophysical characterization techniques, such as CE , DLS, BCA, CD, intrinsic fluorescence, SEC, SEC-MALS et al, and AUC as… more