R&D Pharmaceutical Scientist II – Method Dev & Validation

NCBioImpact; Greenville (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

NCBioImpact is seeking an R&D Scientist II to perform routine analyses in chemistry/biochemistry, supporting process development and manufacturing operations. The role includes method development, validation, and data reporting for HPLC, GC, and related techniques.

Responsibilities emphasize rigorous data review, adherence to regulatory guidelines, and collaboration with project teams to ensure timely delivery and quality.

Qualifications

• Bachelor’s degree in chemistry/biochemistry/molecular biology or related field with 3+ years of experience, or
• Master’s degree with 1+ year pharmaceutical experience preferred.
• Experience with HPLC.
• Experience with HPLC, GC, Dissolution, FT-IR, UV, Karl Fischer Titration, IEF, ELISA, CGE, Dot-Blot preferred.
• Experience with method development and validation, analytical techniques, and chromatographic/spectroscopic methods preferred.
• EMPOWER experience preferred.
• Strong knowledge of chemistry and analytical instrument technologies.
• Awareness of quality and regulatory requirements in pharmaceutical industry.
• Fluent in English.

Responsibilities

• Lead/execute development, evaluation, validation and transfer of test methods for pharmaceutical materials and products.
• Perform testing for strength, impurities, identity, potency, and dissolution by multiple analytical techniques.
• Identify out-of-spec results and communicate issues.
• Review data against specifications and standard procedures.
• Maintain compliance with cGMP, GLP, USP/EP, and data integrity requirements.
• Assist in trainings as SME and participate in client teleconferences.

Skills

Communication skills

Reading procedures

Organizational skills

Attention to detail

Written reports

Education

Bachelor’s degree in Chemistry/Biochemistry/Molecular Biology or related

Master’s degree in related field

Tools

HPLC

GC

Dissolution

FT-IR

UV

Karl Fischer Titration

IEF

ELISA

CGE

Dot-Blot

EMPOWER

Job description

NCBioImpact is seeking an R&D Scientist II to perform routine analyses in chemistry/biochemistry, supporting process development and manufacturing operations. The role includes method development, validation, and data reporting for HPLC, GC, and related techniques.

Responsibilities emphasize rigorous data review, adherence to regulatory guidelines, and collaboration with project teams to ensure timely delivery and quality.