**Method Validation Chemist** Laboratory Oklahoma City, OK, US Pay Rate Low: 37.00 | Pay Rate High: 49.00 + Added - 05/02/2025 Apply for Job _Our client in the biopharmaceutical manufacturing industry is looking for a Quality Control Method Validation Scientist to join their team!_ A successful candidate will work as one of the technical leaders for the analytical methods in the QC department. He/she will be responsible for various activities related to analytical method validation including bioanalytical methods, HPLC/UPLC based test methods for protein analysis, method qualification, and method transfer activities in QC department. **Schedule** : Monday-Friday 8a-5p **Type** : Contract **Pay** : $37-$49/hr **Duties and Responsibilities:** + Prepare method qualification / validation protocols, participate in the execution of the protocols, and prepare final reports per ICH and other regulatory guidelines for various analytical methods for the characterization of biopharmaceutical protein products. + Take independent role in implementing/trouble shooting various assays/test methods in the QC laboratories. + Guide and help laboratory analysts during the method validation / qualification / transfer, and platform method verification/evaluation activities in QC department. + Specify and source new analytical equipment as required to expand the testing capabilities of the QC Analytical Laboratory. + Serve as one of the technical leads for data analysis including appropriate statistical application as required. + Draft and review analytical method related protocols, SOP’s, reports, and other documentation to support ongoing activities in the QC laboratory. + Support the training of new and existing laboratory personnel for Analytical methods including Bioassays. + Perform and evaluate analytical technology transfers associated with new products or processes to QC laboratory. + Provide support as subject matter expert (SME) during Quality Audits, Client Audits, and Audits by the Regulatory Agency. + Other duties as assigned. **Job Requirements:** + Minimum M.S in Life Sciences/Chemistry with **6+ years** of academic /industry experience in method development, method validation/qualification and method transfer + Higher degree ( **PhD** ) and laboratory experience dealing with Analytical Method Validation/Qualification for biologics preferred. + Demonstrated expertise with a range of protein/glycoprotein analytical techniques including HPLC/UPLC, ELISA, icIEF, enzymatic, electrophoretic (SDS-PAGE, Western blots, IEF, and CE), and PCR based test procedures. Cell culture and bioassay/potency assay experience is plus. + A working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable. _Our client in the biopharmaceutical manufacturing industry is looking for a Quality Control Method Validation Scientist to join their team!_ A successful candidate will work as one of the technical leaders for the analytical methods in the QC department. He/she will be responsible for various activities related to analytical method validation including bioanalytical methods, HPLC/UPLC based test methods for protein analysis, method qualification, and method transfer activities in QC department. **Schedule** : Monday-Friday 8a-5p **Type** : Contract **Pay** : $37-$49/hr **Duties and Responsibilities:** + Prepare method qualification / validation protocols, participate in the execution of the protocols, and prepare final reports per ICH and other regulatory guidelines for various analytical methods for the characterization of biopharmaceutical protein products. + Take independent role in implementing/trouble shooting various assays/test methods in the QC laboratories. + Guide and help laboratory analysts during the method validation / qualification / transfer, and platform method verification/evaluation activities in QC department. + Specify and source new analytical equipment as required to expand the testing capabilities of the QC Analytical Laboratory. + Serve as one of the technical leads for data analysis including appropriate statistical application as required. + Draft and review analytical method related protocols, SOP’s, reports, and other documentation to support ongoing activities in the QC laboratory. + Support the training of new and existing laboratory personnel for Analytical methods including Bioassays. + Perform and evaluate analytical technology transfers associated with new products or processes to QC laboratory. + Provide support as subject matter expert (SME) during Quality Audits, Client Audits, and Audits by the Regulatory Agency. + Other duties as assigned. + **Job Requirements:** + Minimum M.S in Life Sciences/Chemistry with **6+ years** of academic /industry experience in method development, method validation/qualification and method transfer + Higher degree ( **PhD** ) and laboratory experience dealing with Analytical Method Validation/Qualification for biologics preferred. + Demonstrated expertise with a range of protein/glycoprotein analytical techniques including HPLC/UPLC, ELISA, icIEF, enzymatic, electrophoretic (SDS-PAGE, Western blots, IEF, and CE), and PCR based test procedures. Cell culture and bioassay/potency assay experience is plus. + A working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ _INDBH #LI-DNP_ We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.