R&D Analytical Scientist II — HPLC/GC Specialist

Pai-Pharma-1; South Carolina; On-site; USD 70,000 - 98,000; Full time

Job summary

PAI Pharma in Greenville, SC, is seeking an Analytical Scientist II to support R&D with method development, validation, and degradation/impurity analysis. You will use HPLC/UPLC, GC, and GC-HS to generate robust data and draft reports for FDA filings.

The role requires GMP/GLP awareness, strong written/verbal communication, and the ability to manage small projects while training junior staff. A BS with relevant experience or MS with limited years is acceptable.

Qualifications

• BS + 4 years relevant experience or MS + 0–2 years relevant experience.
• Experience with HPLC/UPLC, GC and GC-HS for degradation/impurity analysis.
• Ability to develop and validate analytical methods from start to finish.
• Strong documentation and ability to draft reports.

Responsibilities

• Proficient understanding of cGMP/GLP and lab processes.
• Perform routine and non-routine testing on Drug Product, Drug Substance (API) and excipients.
• Perform full Stability Testing on Drug Products to support FDA filings (physical tests, assay and impurity testing).
• Capable of performing investigations independently or with minimal guidance.
• Manage small to medium sized projects and write/ review data and protocols.
• Troubleshoot OOS/OOT/Aberrant results and ensure compliant documentation.
• Maintain a GMP compliant laboratory environment.

Skills

HPLC/UPLC

GC

Method validation

SOP writing

Team collaboration

Troubleshooting

Education

BS + 4 years relevant experience or MS + 0–2 years relevant experience

Tools

Syngistix

OpenLab

Empower

Karl Fischer

Job description

PAI Pharma in Greenville, SC, is seeking an Analytical Scientist II to support R&D with method development, validation, and degradation/impurity analysis. You will use HPLC/UPLC, GC, and GC-HS to generate robust data and draft reports for FDA filings.

The role requires GMP/GLP awareness, strong written/verbal communication, and the ability to manage small projects while training junior staff. A BS with relevant experience or MS with limited years is acceptable.