Nivagen Pharmaceuticals, Inc. · 4 weeks ago
Research Chemist (E&L)
Sacramento, CA 95834
Full-time
Onsite
Mid Level
$70K/yr - $85K/yr
3+ years expNivagen Pharmaceuticals is a global company dedicated to enhancing lives through cost-effective pharmaceutical products. They are seeking an experienced Research Chemist (E&L) to maintain and troubleshoot analytical systems, develop and validate methods, and support regulatory submissions.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
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
Whenever needed, 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
Any other activities as directed by the supervisor
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 3-5 years of pharmaceutical industry experience
Familiarity with the characterization and isolation of impurities
Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques
Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances
Skilled in laboratory techniques for measuring, weighing, and handling samples
Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS)
Competency in Microsoft Office applications
Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius)
Preferred
Hands-on experience with HPLC
Experience or familiarity with current Good Manufacturing Practices (cGMP)
Benefits
Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan
401 (k) savings plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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