Senior Scientist

Role Summary

Senior leader in QC laboratory performing, leading, analyzing and/or documenting laboratory tests within a GMP environment in support of raw materials, in-process product, finished product, stability, sterility and/or validation for microbiological processes. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product specifications. Trains other laboratory personnel on any technique they currently have in their training matrix.

Responsibilities

• Leads and influences analysts in QC with their tasks and activities.
• Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain procedural requirements.
• Performs, leads, analyzes and/or documents analytical test methods as written to support product/material release with minimal error.
• Proposes and implements changes to improve laboratory techniques and methodology.
• Independently troubleshoot and resolve analytical techniques and instrument issues.
• Interprets experimental data for conformance with product/material specifications.
• Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements.
• Implements and ensures improvement ideas are completed to facilitate team objectives. Proposes and implements scientific protocols to determine exception event cause.

Qualifications

• Required: BS degree in Science or equivalent
• Required: 10+ years of relevant experience
• Required: Maintains their certifications as needed for assigned job tasks.
• Required: Demonstrates strong analytical skills and logical thought process.
• Preferred: Experience with aseptic simulation validations