Scientist at The Fountain Group

The Fountain Group is currently seeking a ­­­­­­­­Scientist for a prominent client of ours. This position is located in ­­Social Circle, GA. Details for the position are as follows:

Job Description:

**100% ONSITE**

• Expertise and technical leadership managing instrument/method validations change requests and improvement initiatives.
• Lead/Manage assay qualification and validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with the functional area managers, performing statistical data analysis and final summary reports per ICH and internal guidelines.
• Lead investigator providing technical and analytical representation for, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
• Coordinate analytical support within QC necessary to identify root cause.
• Facilitate major investigations, review of change control requests, provide representation to tech transfer as needed, review of process and method validation initiatives in support of the QC laboratories.
• Provide technical expertise and support for monitoring/assessing analytical method performance, troubleshooting and assay remediation.
• Manage and contribute to cross functional teams.
• Lead management of the document change requests for method SOPs.
• Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
• Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies.

Qualifications:

• BS, MS, or PhD
• Extensive GMP/CMC pharma experience (7+ years)
• Chromatography/Spectroscopy experience
• Analytical Method Validation

Compensation: Up to $83.93 per hour