Scientist I- Immunoassay
📋 Role Overview & Responsibilities
Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.
ResponsibilitiesPrepare reagents, standards, and control samplesAnalyze samples using various techniques specific to departmentPerform complex method development with limited supervisionPerform method validation or qualificationOperate analytical equipmentLead 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 wasteRecord tasks in accordance with Good Documentation Practices (GDP)Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11Follow applicable SOPs and procedural documentsOther tasks as assigned
Education, Experience & Skills RequiredBA/BS or higher with 7-8 years lab experience; all experiences will be evaluatedKnowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMPAble to independently 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 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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