Research Chemist - Analytical

1d1 day ago

Nivagen Pharmaceuticals

Sacramento, US · Full-time · $75,000 – $85,000

About this role

Nivagen Pharmaceuticals is a global company dedicated to enhancing lives by developing cost-effective generic prescription drugs and over-the-counter products. We seek an experienced Research Chemist (Analytical) with 2-5 years pharmaceutical industry experience. The role involves analytical development for complex parenteral drug products including peptides, suspensions, solutions, and lyophilized products.

Daily responsibilities include maintaining and troubleshooting LC-MS systems, performing extraction and analysis of extractables and leachables from polymeric materials per PQRI and ICH guidelines. Develop and validate LC-MS methods for finished products, raw materials, and testing. Identify unknown impurities using LC-MS/MS and interpret complex spectral data.

Join a collaborative team of professionals advancing manufacturing, distribution, and quality control through vertical integration and cutting-edge technology. Provide critical review of analytical data, reports, and protocols. Support preparation of methods and study reports for ANDA/NDA submissions.

Attend SOP, safety, and scientific trainings to remain current with cGMP regulations and development technologies. Benefit from robust training and development opportunities in a culture fostering growth and support. Empower your team to drive innovation and impact healthcare accessibility.

Requirements

Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum 2-5 years pharmaceutical industry experience
1-2 years hands-on experience handling LC-MS systems (QTOF, Tandem Quad)
Familiarity with characterization and isolation of impurities
Strong foundation in organic chemistry and structural elucidation
Expertise in small molecule pharmaceutical drug development and peptides, including computational techniques
Proficiency in using standard laboratory equipment, including pipettes and graduated cylinders

Responsibilities

Maintain, operate, and troubleshoot LC-MS systems
Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials per PQRI, ICH, and regulatory guidelines
Develop and validate LC-MS methods for finished product, raw material characterization, and extractable/leachable testing
Identify unknown impurities using LC-MS, LC-MS/MS, or other suitable techniques
Interpret complex spectral data and fragmentation patterns
Conduct routine stability testing of API and finished product samples for assay and impurities using LC-MS
Generate study designs, write protocols, methods, datasheets, and reports
Prepare and review analytical methods, method validation, and study reports for ANDA/NDA submissions