Senior Analytical Scientist, GMP Method Development

MedPharm Ltd; Durham (NC); Hybrid; USD 95,000 - 145,000; Full time

Job summary

MedPharm Ltd. seeks an experienced Scientist III/Senior Scientist to develop and validate analytical methods supporting drug formulation development in a GMP laboratory. You will manage projects end-to-end, perform stability studies, write validation protocols, and troubleshoot HPLC/GC instruments while ensuring data integrity.

You will collaborate with Formulation R&D, Quality Control, and Quality Assurance, mentor junior scientists, and maintain a compliant lab environment. Travel is minimal.

Qualifications

• B.S. or higher in chemistry/related field with strong GMP exposure.
• Experience in developing and validating GMP-compliant HPLC/GC methods.
• Proven ability to lead projects and mentor junior scientists.

Responsibilities

• Develop and validate analytical methods to support formulation drug development under minimal supervision.
• Perform routine testing including stability testing and solubility studies.
• Own projects independently from literature review to data delivery.
• Author/validate protocols, development reports, and SOPs.
• Troubleshoot HPLC and GC instrumentation and address OOS/OOT results.
• Mentor and develop junior scientists; present data to customers.

Skills

Method validation

HPLC troubleshooting

GC troubleshooting

Regulatory compliance

Mentoring

Literature reviews

Education

B.S. in Chemistry

M.S. in Chemistry

Ph.D. in Chemistry/Biology/Pharmaceutics

Tools

HPLC

GC

Empower 3 software

MasterControl

Job description

MedPharm Ltd. seeks an experienced Scientist III/Senior Scientist to develop and validate analytical methods supporting drug formulation development in a GMP laboratory. You will manage projects end-to-end, perform stability studies, write validation protocols, and troubleshoot HPLC/GC instruments while ensuring data integrity.

You will collaborate with Formulation R&D, Quality Control, and Quality Assurance, mentor junior scientists, and maintain a compliant lab environment. Travel is minimal.