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Baxter Chemistry Research Associate Job Opening – Apply Online
Research Associate – II, Nitrosamine
Req # JR – 157598
Location: Ahmedabad, Gujarat, India
Job Category: Research and Development
Date Posted: 12/19/2024
Research Associate II – Nitrosamines (Characterization Team)
Baxter Pharmaceuticals R&D is seeking a highly motivated scientist with proven expertise in liquid chromatography and mass spectrometry to join its Characterization team. As a catalyst within the Pharmaceuticals Global Business Unit, the successful candidate will apply state-of-the-art technologies in LC-MS and GC-MS in support of new and existing pharmaceutical products. The scientist in this role will support Nitrosamine studies (core), extractables and leachable studies, using mass spectrometry-based approaches to identify nitrosamines, potential leachables from container extracts, and develop and validate LC/MS methods to quantify NA impurities and leachable compounds in finished drug product solutions.
What you’ll be doing!
- Develop, validate, and transfer methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels.
- Involve in the design of experiments for identifying the root cause of Nitrosamine impurities formation and developing mitigation strategies.
- Perform chemical extractions of container closure systems and drug product solutions in the laboratory.
- Apply state-of-the-art mass spectrometry-based approaches to solve challenging problems and develop/validate novel mass spectrometry-based analytical methods.
- With the help of SME/Supervisor:
- Plan, execute, and manage projects/programs that span multiple disciplines and utilize established methods, techniques, or approaches.
- Prepare/propose the technical feasibility of complex design concepts within areas of expertise.
- Advise management regarding appropriate action.
- Interpret data, evaluate analytical results, and identify trends/exceptions relative to product requirements, definitions, and/or project goals.
- Reach conclusions based on research analysis and incorporate recommendations into larger projects.
- Share research outcomes and methodologies with team members and other divisional personnel.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements to ensure compliance in all research, data collection, and reporting activities.
- Maintain an in-depth understanding of GxP regulations and provide insights to facilitate efficient product registration.
- Actively participate in the review, adoption, and interpretation of such regulations.
What you’ll bring!
- Master’s degree or equivalent experience with at least 6-10 years OR PhD or equivalent experience with 4-6 years in a relevant discipline.
- Formal training in mass spectrometry with expertise in conducting sophisticated experiments, such as accurate mass and MS/MS, and interpreting mass spectrometric data.
- Strong knowledge of organic chemistry and other analytical fields, such as chromatography, NMR, and IR.
- Skills in elucidating unknown compound structures using a multidisciplinary approach are an advantage.
- Preferred experience in:
- Nitrosamine, E&L testing/study design, environmental chemistry testing, and/or trace organic analysis.
- Complex method development and validation, particularly for quantitative LC/MS methods.
- Ability to make routine and some non-routine decisions independently.
- Effective collaboration with internal and external partners.
- Experience working in a regulated pharmaceutical environment (e.g., cGXP) is preferred.
- Ability to learn quickly and address problems in a timely manner using analytical chemistry skills.
Link to Original Notification to apply: APPLY ONLINE HERE
Keywords: Baxter Pharmaceuticals, Research Associate, Nitrosamine, LC-MS, Mass Spectrometry, Pharmaceutical Products, Laboratory, Analytical Chemistry, GxP Regulations. Baxter Chemistry R&D Job Opening – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
