Analytical Scientist II: HPLC/GC Method Dev & GMP

PAI Pharma; Greenville (SC); On-site; USD 70,000 - 90,000; Full time

Job summary

PAI Pharma in Greenville, SC, seeks an Analytical Scientist II to advance analytical method development and validation for drug products. The role focuses on degradation/impurity analysis, residual solvents, and API assays.

You will perform method development, validations, and draft reports, while maintaining GMP standards and contributing to FDA filings. The successful candidate will have strong hands-on experience with HPLC/UPLC and GC, proficiency in chromatographic software, and the ability

Qualifications

• Requires knowledge of cGMP/GLP and basic lab techniques.
• Ability to write and review analytical data, methods, and reports.
• Experience with HPLC/UPLC and GC instruments and troubleshooting.

Responsibilities

• Perform routine and non-routine testing on Drug Product, Drug Substance, and excipients.
• Conduct stability testing to support FDA filings and related testing.
• Develop and validate/verify analytical methods and protocols.
• Maintain GMP-compliant lab environment and detailed records.
• Provide training to junior scientists as needed.
• Troubleshoot OOS/OOT and investigate aberrant results.

Skills

HPLC/UPLC

GC

Chromatographic software

pH

Karl Fischer

UV/Vis

FTIR

Particle Size Analysis

Wet Chemistry (USP tests)

OOS/OOT investigations

Education

BS in Chemistry or related field

MS in Chemistry or related field (optional)

Tools

Syngistix

OpenLab

Empower

LC/MS

GC/MS

ICP/MS

Job description

PAI Pharma in Greenville, SC, seeks an Analytical Scientist II to advance analytical method development and validation for drug products. The role focuses on degradation/impurity analysis, residual solvents, and API assays.

You will perform method development, validations, and draft reports, while maintaining GMP standards and contributing to FDA filings. The successful candidate will have strong hands-on experience with HPLC/UPLC and GC, proficiency in chromatographic software, and the ability