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Associate Scientist

Company name
Apex Life Sciences

Location
San Diego, CA

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Job Description
Our client, a world renowned leader in biotech in San Diego, is seeking an Associate Scientist. \r\rDuties\r\rThis position provides technical collaboration for product development programs or projects involving department or cross-functional teams focused on validation of inspection methods used during assembly of consumable products.\r\rResponsibilities\r\r\rEnzyme assay development and validation for fluorescent plate based analytical methods, used in qualifying consumable products\rDevelop and execute validation protocols for inspection methods used at all levels of consumable manufacturing\rAnalyze test results, draft validation/engineering reports, trouble shoot and make technical recommendations\rEnsure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO\rAll listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.\r\r\r

Job Requirements
\rStrong enzyme assay development background, using plate based fluorescent spectroscopy.\rAt least 3-5 years of experience in analytical method development.\rKnowledgeable in qualification, validation and QC transfer.\rMinimum 2-3years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports, validation master plans\rMust be an effective communicator, able to effectively lead teams and interface well with the organization\rKnowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls\rExperience with statistics, Statistical Process Control and DOE techniques is desired\r\r\rEducation\r\r\rB.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field\r

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Apex Life Sciences

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