Analytical Scientist III

PAI Holdings LLC•Greenville, SC

10h

About The Position

The Analytical R&D Scientist III position requires skill and knowledge of various separation science platforms such as HPLC/UPLC, GC and GC-HS, with a focus on degradation/impurity analysis, API/Preservative Assays and Residual Solvent analysis. This position develops these methods, performs method validations/verifications from start to finish and drafts the associated protocols and reports. Additionally this position requires knowledge and skill at basic analytical laboratory techniques.

Requirements

Separation sciences will be the key focus area of the candidate's work. Expertise and proven ability to apply his/her knowledge to establish analytical methods as per FDA guidelines.
Strong background in HPLC/UPLC, GC and GC-HS; Excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches are required.
Proficiency with the use of chromatographic software applications such as Syngistix, OpenLab, and Empower.
Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.
Proven capability of evaluating/developing new technologies in an independent manner and be able to propose/design implementation strategies if deemed appropriate (e.g. method comparability approaches).
The successful candidate is expected to be an independent, self-driven team player who is ready to provide guidance and mentorship to junior staff as a direct supervisor or in a matrix setting.
Bachelor of Science + 6 years relevant experience or Masters Degree + 2 years relevant experience.

Nice To Haves

Experience with and/or knowledge of the regulatory requirements including knowledge of appropriate control and testing strategies.
Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered an advantage.

Responsibilities

Focus on various separation science platforms such as HPLC/UPLC, GC and GC-HS, with a focus on degradation/impurity analysis, API/Preservative Assays and Residual Solvent analysis.
Develop and complete validation/verification of complex analytical methods to support product release and stability testing.
Design, prepare, and execute method validation/verification protocols and reports, analytical methods, and SOPs. Ensure that the documents adhere to GDP requirements and ICH guidelines.
Manage assigned projects
Conduct troubleshooting
Perform laboratory investigations and prepare necessary reports as needed
Supporting timely deficiency responses
Evaluating, troubleshooting, and improving existing analytical methods when necessary.
Demonstrates strong ability to maintain consistency with organizational objectives while providing imaginative and practicable technical solutions to an array of difficult problems.
Proficiency in basic laboratory techniques such as: pH, Karl Fischer, UV/Vis, FTIR, Particle Size Analysis, etc.
Demonstrates ability to assist in training junior scientists on analytical techniques
Maintain a GMP compliant laboratory environment.
Interface with third-party contract laboratories.