Senior Analytical Method Scientist

MedPharm; Durham (NC); On-site; USD 95,000 - 135,000; Full time

Job summary

MedPharm in Durham, NC seeks a Scientist III/Sr. Scientist to develop and validate analytical methods for formulation drug development in a GMP lab.

The role includes performing validations, stability testing, and forced degradation studies, while ensuring data integrity and regulatory compliance. The candidate will independently manage projects, author development and SOP documents, troubleshoot HPLC/GC instrumentation, and mentor junior scientists in collaboration with Formulation R&D, Quality

Qualifications

• B.S. with 8+ years' GMP laboratory experience.
• 4+ years’ GMP lab experience.
• Proven track record developing/validating GMP-compliant HPLC and GC methods for drug product stability.
• Experience developing methods for topical drug products is a plus.
• Experience diagnosing/troubleshooting HPLC instrumentation; addressing OOS/OOT results.
• Experience with HPLC/GC operation.
• Experience with Empower 3 software.
• Experience with UV, FTIR, KF, microscopy, PSD, viscosity, rheology a plus.

Responsibilities

• Develop and validate analytical methods to support formulation drug development under minimal supervision.
• Perform routine testing including stability testing, solubility studies, and Drug-Excipient Compatibility studies as needed.
• Own projects independently including literature review, material sourcing, design experiments, executing/delegating tasks and providing data to customers.
• Perform forced degradation studies.
• Author product development reports and investigation reports.
• Author/Co-author analytical methods, validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc.
• Execute routine instrument troubleshooting, peer review of laboratory notebooks, maintenance of logbooks.
• Maintain laboratory equipment, including calibration scheduling, acquisition, and basic maintenance programs.
• Maintain a GMP-compliant analytical laboratory and safe working environment, maintain lab inventory.
• Review laboratory notebooks, data packs, and reports under minimal supervision; trend stability data.
• Present data to customers, attend client meetings as needed under minimal guidance.
• Supervise, mentor, train and develop junior scientists.

Skills

HPLC

GC

Empower 3

UV

FTIR

KF

instrument troubleshooting

data integrity

GMP compliance

ICH/USP/FDA guidelines

MS Office

MasterControl

Education

B.S. in chemistry or related field

M.S. or Ph.D. in chemistry/ pharmaceutics

Tools

Empower 3

MasterControl

MS Office

Job description

MedPharm in Durham, NC seeks a Scientist III/Sr. Scientist to develop and validate analytical methods for formulation drug development in a GMP lab.

The role includes performing validations, stability testing, and forced degradation studies, while ensuring data integrity and regulatory compliance. The candidate will independently manage projects, author development and SOP documents, troubleshoot HPLC/GC instrumentation, and mentor junior scientists in collaboration with Formulation R&D, Quality