Kashiv BioSciences, LLC

The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.. Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory.. Strong background in small molecule and protein chemistry and experience troubleshooting analytical results.. Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.

qc analyst

Job Type Full-time Description The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required. <ul><li>Analytical testing to support product in-process, release, and stability programs. </li><li>Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance. </li><li>Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans. </li><li>Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports. </li><li>Performs other functions as required or assigned. </li><li>Complies with all company policies and standards. </li> </ul> Requirements Education: <ul><li>Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas with 6 years of experience in a pharmaceutical/biotech QC laboratory. </li> </ul> Experience: <ul><li>Previous experience in a cGMP laboratory. </li><li>Strong background in small molecule and protein chemistry and experience troubleshooting analytical results. </li><li>Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods. </li> </ul> Specialized Knowledge and Skills: <ul><li>Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. </li><li>Previous experience supporting regulatory inspections (e.g. PAI). </li><li>Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies. </li> </ul>#J-18808-Ljbffr

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