Job description

Title: Research Scientist Location: Exton, Pa Schedule: M-F 8am-4:30pm with the possibility of occasional weekends or off-shifts Type: 6 month Contract to Hire Start date: Immediate Responsibilities: Execute Analytical Test Methods for bulk intermediate testing and final product release testing. Execute testing for raw materials. Author and revise QC SOPs and ATMs as necessary to maintain compliance. Review of Quality Control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product. Timely response to Out of Specification (OOS) results, including notification to area supervision. Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule. Maintain housekeeping in the laboratories. Assist the Quality Control Supervisor in daily operations, as needed. Authoring and/or executing protocols and generating technical reports. Analytical test method qualification and validation. Equipment qualification and preventative maintenance. Training of other employees. Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact is assessed, and actions to prevent recurrence are considered and implemented. Requirements: Minimum Bachelor of Science degree in a scientific discipline 2-3 years’ experience in mammalian cell culture in an academic or industrial laboratory Knowledge of basic laboratory skills (use of micropipettes, aseptic technique, etc.) are required. Knowledge of Current Good Manufacturing Practice and Industry standards Familiarity with analytical equipment including UV absorbance plate readers, Flow cytometers, microscopes, automated cell counters, and PCR thermal cyclers. Experience with analytical testing methods such as ELISAs, Flow Cytometry, and qPCR Must be open to occasional off shift and weekend work.

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