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