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Job Description About the Company: 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. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. 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. Education/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., • Hands-on experience with HPLC (highly preferred)., • Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS)., • Competency in Microsoft Office applications., • Pay range $70,000 - $85,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.