Research Chemist (E&L)

1d1 day ago

Nivagen Pharmaceuticals

Sacramento, US · Full-time · $70,000 – $85,000

About this role

Nivagen Pharmaceuticals seeks an experienced Research Chemist (E&L) to enhance pharmaceutical quality control. Focus on extractables and leachables from container closure systems using LC-MS, GC-MS, and ICP-MS. The role supports vertical integration and regulatory compliance in generic drug development.

Maintain and troubleshoot advanced instrumentation like LC-MS, GC-MS, GC-FID, and ICP-MS daily. Perform extractions, analyses, and characterizations per USP, PQRI, ICH guidelines. Develop optimized sample preparations and validated methods for raw materials and finished products.

Collaborate with the team on stability testing, impurity identifications, and data reviews. Train new recruits, write SOPs, and support technical transfers between R&D and QC. Participate in internal meetings and scientific conferences.

Grow through robust training on cGMP, safety, and technologies. Prepare protocols, reports, and documents for ANDA/NDA submissions. Contribute to a culture prioritizing employee well-being, integrity, and innovation in healthcare.

Requirements

Minimum 3-5 years of pharmaceutical industry experience
Familiarity with characterization and isolation of impurities
Strong foundation in organic chemistry
Proficiency in LC-MS, GC-MS, GC-FID, and ICP-MS operation and troubleshooting
Experience developing and validating analytical methods for extractables and leachables
Knowledge of USP, PQRI, ICH, and other regulatory guidelines
Ability to interpret mass spectral data and fragmentation patterns

Responsibilities

Maintain, operate, and troubleshoot LC-MS, GC-MS, GC-FID, and ICP-MS systems
Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials per USP, PQRI, ICH guidelines
Develop and optimize sample preparation techniques for GC-MS, LC-MS, and ICP-MS analysis
Develop and validate LC-MS, GC-MS, and ICP-MS methods for extractable/leachable testing and product characterization
Identify unknown impurities using GC-MS, LC-MS, LC-MS/MS techniques
Interpret complex spectral data and fragmentation patterns
Conduct routine stability testing of API and finished products for assay and impurities
Generate study designs, write protocols, methods, datasheets, and reports