Analytical Scientist II

PAI Holdings LLC•Greenville, SC

6d•Onsite

About The Position

The Analytical R&D Scientist II 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 assists in developing 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

Ability to work independently and effectively prioritize tasks.
Ability to take direction from senior team members.
Strong written and verbal communication skills.
Demonstrates initiative in learning new skills and concepts
Strong background in HPLC/UPLC and GC; Advanced instrument and method troubleshooting skills are required.
Proficiency with the use of chromatographic software applications such as Syngistix, OpenLab, and Empower.
Proficiency in basic laboratory techniques such as pH, Karl Fischer, UV/Vis, FTIR, Particle Size Analysis, etc.
Proficiency in performing Wet Chemistry analyses (such as USP Identification Tests).
Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.
Capability of independently completing full monograph testing of Stability Samples to support FDA filings.
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
Knowledge of ICH/USP guidelines relating to analytical method validation/verification.

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.
Basic knowledge of LC/MS, GC/MS and ICP/MS instrumentation and techniques (Such as Elemental Impurities, Extractable/Leachables and Nitrosamines) will be considered an advantage.

Responsibilities

Proficient understanding of knowledge in the areas of: cGMP/GLP Understanding, Working with standard lab equipment, instruments, and processes, Working principles of major analytical techniques
Perform both routine and non-routine testing on Drug Product, Drug Substance (API) and excipients.
Perform full Stability Testing on Drug Products to support FDA filings. (including Physical tests, Assay and Impurity testing)
Perform preliminary testing on products in the Development phase as requested by the Product Development group.
Capable of performing investigations independently or with minimal guidance, and able to assist in developing related procedures.
Demonstrates ability to manage small to medium sized projects.
Ability to accurately write and review analytical data, test methods, validation/verification protocols, and reports.
Demonstrates ability to develop less complex methods as needed.
Ability to provide solutions to various technical problems of moderate scope and complexity.
Perform troubleshooting of OOS/OOT/Aberrant results
Ability to perform timely and precise peer reviews of fellow Scientist’s work.
Willingness to train lower-level scientists on new skills.
Maintain a GMP compliant laboratory environment.