Independent scientist who demonstrates technical knowledge and contributes to the overall operations of the Viral Clearance Department. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Performs and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Acts as Study Director as required.
• Demonstrates scientific technical expertise.
• Effectively communicates and defends science through written and verbal communication.
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting.
• Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
• As assigned by Management, acts as Study Director for specific assays and assumes all associated responsibilities.
• Trains new personnel in lab procedures.
• Effectively interacts with clients as required.
• Schedules lab work.
• Communicates with supervisor and other colleagues re: daily lab activities.
• Prepares and revises technical documents and reports.
• Reports date changes for testing and other pertinent information to clients via Project Management Department.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• 5 years of relevant experience or equivalent
• Bachelors’ degree in Biological Sciences or other science related major or equivalent experience
• Must have experience with aseptic technique, mammalian cell culture, and has worked with various types of viruses
• Specialized training in laboratory techniques used in assigned laboratory is required.
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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