Division Overview Aurolife was founded in 2008 as part of a group of companies with a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization have given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control, and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife aims to provide healthcare at economical prices to make this a healthier world to live in. Job Overview A highly skilled scientist with a background in chemistry and experience in the pharmaceutical industry. Proficient in LC-MS/MS techniques for the analysis and characterization of Nitrosamine/NDSRI impurities and small molecules. Expertise in method development, validation, and technology transfer, with strong knowledge of manufacturing, analytical, and quality control processes. Skilled in trace-level quantification of impurities using various analytical techniques, including LC-UV/FID, Ion Chromatography, and LC-MS. Experienced in Mass Spectrometry software (MassLynx™, Analyst™) and troubleshooting LC-MS/MS equipment. Familiar with OOS/OOT investigations, laboratory safety, and controlled substance handling. Possesses strong technical writing, documentation, and de-formulation experience in various drug product formulations, including topical, transdermal, MDI, and solid oral products. Responsibilities Meet quality, quantity, and timelines in all assigned projects; Perform and document scientific experiments; Plan & organize scientific experiments under minimal guidance from more experienced team members. Seeks proactive support and coaching from the Project Leader, Scientific Expert, or other team members if necessary. Provide documentation of raw data; Evaluate and Contribute to interpretation and report results under minimal guidance from more experienced team members; Propose and provide input for the design of next experiments; Optimize existing methods (lab or plant) or contribute to new method development and reproduce published methods and develop more efficient ones. Generate lab procedures, reports and/or instructions and/or SOPs; Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls, etc.; Communicate and address problems, perform safety and literature searches under moderate guidance from a more experienced team member. Keep a record of and manage chemicals, intermediates, excipients, and solvents within your area of responsibility. Ensure all activities align with the overall work according to appropriate SOPs, GMP, GLP, QM, & Aurobindo Guidelines; make strategic and scientific contributions to networks and target achievements according to network charter and annual objectives. Qualifications - Skills & Requirements Experience working with LC-MS/MS techniques supporting Nitrosamine /NDSRI impurities and characterization of small molecules. Method Development, Validation, tech transfer of Nitrosamine/NDSRI methods and routine analysis of various samples. Broad theoretical and scientific knowledge in the relevant area (e.g., manufacturing, analytical, Quality Control, and pharmaceutical). Skilled scientist with expertise in trace-level quantification of GTI/ Nitrosamines/Nitrites or similar impurities using LC-UV/FID, Ion chromatography, and LCMS. Experience with MassLynx™, Analyst™, or other Mass Spectrometry data-acquisition software packages. The ability to perform routine maintenance/troubleshooting on LC-MS/MS equipment Experience dealing with OOS/OOT and deviations involving the above-mentioned analytical techniques. Proficient with laboratory and/or technical tools and awareness of handling of the control substance materials. Awareness of safe handling of chemicals, potentially dangerous materials, and equipment Good knowledge of software and computer tools and good documentation skills. Advanced scientific/technical writing skills Wide experience in de-formulation studies of drug products, especially in Topical, Transdermal, MDI, and solid oral products. Education & Experience Education & Experience Minimum BS(undergraduate)/MS(Graduate) in relevant scientific discipline covering chemistry with experience in the pharma industry. Must have at least 5 years of experience. Physical Requirements LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. • Must practice good personal hygiene • Must be able to lift up to 25 lbs. • Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. • Position requires working in the laboratory as well as sitting Additional Physical Requirements Hand Manipulation is required - Simple Grasping Right HandHand Manipulation is required - Power Grasping Left HandHand Manipulation is required - Pushing & Pulling Right HandLifting 8+ Hours - 10-15 PoundsTwisting 1-4 HoursKneeling 1-4 HoursStanding 4-8 HoursBending 1-4 Hours Blood/Fluid Exposure Risk Category I: Tasks involve exposure to blood, fluids or tissue.