R&D Chemist II — GMP Method Development & Analytics

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

RXinsider LTD. is seeking an experienced pharmaceutical analytics scientist to lead R&D projects across established and new products. You will validate and transfer analytical methods (LCMS/HPLC/UPLC, GC, FT-IR, UV/Vis) and generate GMP data in a fast-paced environment.

The role emphasizes method development, troubleshooting, and collaboration with QA and regulatory teams to ensure compliant documentation and timely submissions.

Qualifications

• Regionally accredited Master’s Degree in Chemistry with 8–10 years of cgmp experience.
• Experience with analytical methods including LCMS, HPLC/UPLC, GC, FT-IR, UV/Vis.
• Experience in method development, validation, transfer, and troubleshooting.
• Ability to draft and review protocols and reports; strong communication.

Responsibilities

• Perform research and development projects for established products and new products including analytical test method validation/transfer/verification, deformulation, procedures, investigations, and other non-specified projects or initiatives.
• Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence.
• Oversee and ensure reports, submission documentation, and development summaries documenting the product development process for clients, partners, and health authorities (FDA).
• Participates in development and implementation of associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation).

Skills

LCMS

HPLC

UPLC

GC

FT-IR

UV-Vis

Wet chemistry

Analytical method development

Troubleshooting

Communication skills

MS Office

Education

Master’s Degree in Chemistry

Tools

MS Office

Job description

RXinsider LTD. is seeking an experienced pharmaceutical analytics scientist to lead R&D projects across established and new products. You will validate and transfer analytical methods (LCMS/HPLC/UPLC, GC, FT-IR, UV/Vis) and generate GMP data in a fast-paced environment.

The role emphasizes method development, troubleshooting, and collaboration with QA and regulatory teams to ensure compliant documentation and timely submissions.