Covance's GMP regulated lab is seeking a Research Associate II to join their Protein Chemistry group in Greenfield, IN.
This position provides an opportunity to further enhance your assay development skills, while functioning in a leadership capacity.
If the keywords below sound familiar to you please do not hesitate to apply to become a valued employee of the world's largest drug development CRO.
Keywords: Size Exclusion Chromatography, Reverse Phase, Peptide map, CE-SDS, Compendial assays (pH, physical appearance)
•Independently analyze samples and/or validate methodologies for various compounds and components in compliance with appropriate SOPs and regulatory agency guidelines.
•Troubleshoots assays, with minimal guidance.
•Document work and maintain study documentation and laboratory records.
•Recognizes deviations from expected results and recommends appropriate action.
•Suggests and performs modifications to test methods or procedures based on existing precedence, or technical experience in area of responsibility.
•Identifies and takes appropriate action with problems or potential problems in technical area of responsibility.
•Ability to implement an action plan for solving project or technical problems as they occur.
•Independently sets up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
•Support the implementation of startup priorities, systems and SOPs for the biotechnology group.
•Serve as primary analyst on projects, overseeing a small group of technical personnel, with supervision.
•Provides input and may lead projects.
•Plan, monitor and guide project work.
•Ability to write, revise, and review SOPs and methods for compliance with regulatory guidelines.
• BS/BA degree in science or related field; MS or PhD preferred
• This is a hands on position
• Strong ability to learn is required
• Demonstrates excellent oral and written communication skills
• Strong interpersonal skills
• Organizational skills
• Must be able to work in a laboratory setting.
• 2-3 years of experience in the biotechnology, biopharmaceutical or pharmaceutical industry
• 5-6 years of scientific experience relevant to the technical area of responsibility
• Broad based technical experience and demonstrated ability to learn is required
• Experience with equipment and analysis related to technical area of responsibility is required
• Experience in a high throughput regulated environment strongly preferred
• GMP compliance experience helpful
• Experience with laboratory-related computer systems is required