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Ph. D. or master’s degree with equivalent level of experience, in Chemistry, Biochemistry, Chemical Engineering or related field. Experience with assay development, optimization, qualification and validation for protein therapeutics.
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BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related field from an accredited university with 1+ years of experience for MS or 2+ years of experience with BS.
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PhD in biochemistry, biological science, or chemical engineering or related fields with 6+ years of relevant experience, or BS/MS with 10+years of relevant experience in biopharmaceutical organization with expertise in drug substance development and/or tech transfer.
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Basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms. Supporting process development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations.
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Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience.
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Bachelor's degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline). Knowledge of Lean Six Sigma, technical writing, SAS JMP or other statistical software, and Laboratory Information Systems (LIMS) are preferred.
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Top Skills: Stability Testing; Sample Management; Biological Samples; Laboratory Environment; Technical Writing. Responsible for all aspects of on-site stability sample storage and sample management. Previous experience with SAS JMP or other statistical software preferred.
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Previous experience with Laboratory Information Systems (LIMS) preferred. The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.
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Knowledge of Lean Six Sigma preferred. Able to navigate external vendor sites and portals for data extraction and review, as needed. Author stability Protocols, Reports, SOPs and Quality documents as required.
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Point-of-contact between on-site testing labs and stability group. Able to organize his/her own work on a routine basis and requires minimal supervision. Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans.
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In an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience.
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In Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 2+ years of experience OR MS degree with 1+ years of relevant experience is required. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
$27 - $29.5 an hourTemporaryExpandApply NowActive JobUpdated Today
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