Sr. Scientist I- Immunoassay
📋 Role Overview & Responsibilities
Independently design and develop methods, and complete complex lab work, sample analysis, validation, and method development
ResponsibilitiesPrepare reagents, standards, and control samplesAnalyze samples using various techniques specific to departmentIndependently design and develop methodsPerform method validation or qualificationOperate analytical equipmentTechnical resource for troubleshooting activities; assays and equipmentMaintain analytical equipmentReview, evaluate, and interpret data resultsDraft and present posters/presentationsTrain and mentor lower level ScientistsCollaborate with clients and vendorsEnsure lab area is clean and inspection ready at all timesRemove lab wasteCollaborate across teams, departments, and sitesEvaluate and establish processes to improve quality and efficiencyRecord tasks in accordance with Good Documentation Practices (GDP)Knowledge of regulatory requirements; GLP, GCP, 21CFR Part 11Follow applicable SOPs and procedural documentsOther tasks as assigned
Education, Experience & Skills requiredBA/BS or higher with 11-12 years lab experience; all experiences will be evaluated orPhD in relevant field with 3-5 years lab experienceKnowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMPAble to independently develop and perform complex lab workAble to work in a regulated environmentAble to work effectively and contribute within a teamAble to work with computer systemsAble to document clearlyAble to communicate clearlyKnowledge of and experience in a regulatory environment
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This position is located in Malvern, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
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