Research Chemist (E&L)

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience.

Requirements

• Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems.
• Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines.
• Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems.
• Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing.
• Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques.
• Interpret complex spectral data and fragmentation patterns.
• Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries.
• Generate study designs, write protocols, methods, Datasheets and reports.
• Provide support in the critical review of analytical data, reports and protocols.
• Write Instrument-related SOPs and provide training on the instrument and related software.
• Train new recruits in the lab and support the team as needed.
• Participate in internal meetings and conferences.
• Provide support during technical transfer between R&D and QC.
• Attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies.
• Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions.

Benefits

• Pay range $70,000 - $85,000 per Year
• Yearly bonus eligibility
• Medical, dental and vision coverage
• Paid time off plan
• 401 (k) savings plan