- ThermoFisher Scientific (Middleton, WI)
- …class or making employment selection decisions._ **Knowledge, Skills, Abilities** + Experience with HPLC , CE , iCE, or ELISA strongly preferred + Knowledge of ... routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines. + Knowledge of applicable regulatory authority, compendia and ICH guidelines. + Demonstrates excellent manual dexterity skills, allowing for precise and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …support late-stage biologics programs. With a deep focus on separation-based techniques (eg, U/ HPLC , CE -SDS, icIEF, glycan profiling, etc), you will lead a team ... + Develop and implement high-quality analytical methods using separation-based techniques (U/ HPLC , CE -SDS, icIEF, SEC, glycan profiling, etc). + Apply… more
- Sanofi Group (Waltham, MA)
- …+ Knowledge of analytical and biophysical characterization techniques, such as DLS, HPLC , CE -SDS, DSC, CD, PCR, and fluorescence spectroscopy + Ability ... religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional… more
- Amgen (Cambridge, MA)
- …in-depth expertise in multiple analytical techniques (ie, SE- HPLC , icIEF, IEX- HPLC , RP- HPLC , CE -SDS, LC-MS); characterization of protein modifications ... with glycan mapping and peptide mapping. + Experience in method development, qualification, transfer, troubleshooting, method validation, and complex investigations. + Familiarity with and understanding of United States Pharmacopeia (USP) monographs and… more
- 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
- US Tech Solutions (Cambridge, MA)
- …laboratory equipment and with one or more major laboratory instruments/techniques ( HPLC , CE , physical property testing) + Effectively trouble-shoots equipment ... experience in biopharma working on bioanalytical assays such as SEC HPLC , Ion Exchange HPLC , and some basic assays like pH, osmolality, protein concentration… 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