Research Associate - II, Nitrosamine

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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.

• Develop, Validate and Transfer methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub ppb levels.
• Involve in design of experiments for identification of root cause for formation of Nitrosamine impurities 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. Develop and validate novel mass spectrometry-based analytical methods.
• With the help of SME/Supervisor: plan, execute, and manage projects/programs that both span multiple disciplines and utilize established methods, techniques, or approaches.
• Prepare/propose technical feasibility of complex design concepts within area of expertise; advise management regarding appropriate action.
• Interpret data, evaluate analytical results, 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 methodology with team members and other divisional personnel.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development to ensure compliance in all research, data collection, and reporting activities.
• Maintain an in-depth knowledge and understanding of GxP and related regulations and guidance. Be able to provide insights into such regulations so as to facilitate efficient product registration. Be an active participant in the review, adoption, and interpretation of such regulations.

• Masters' degree or equivalent experience with at least 6-10 years, or PhD or equivalent experience with 4-6 years in relevant discipline required.
• Must have formal training in mass spectrometry. Must be skilled in carrying out sophisticated mass spectrometric experiments, such as accurate mass and MS/MS, and in the interpretation of mass spectrometric data.
• Must have good knowledge of organic chemistry and other analytical fields, such as chromatography, NMR, IR, etc. Advantage if possess skills, or demonstrated scientific background for the development of the vital skills, for the elucidation of unknown compound structure using a multidisciplinary approach.
• Experience in Nitrosamine, E&L testing/study design, environmental chemistry testing, and/or trace organic analysis preferred.
• Experience with complex method development and validation, particularly for quantitative LC/MS methods, preferred.
• Ability to make routine, and some less routine, decisions independently.
• Can effectively collaborate with internal and external partners.
• Experience working in a regulated pharmaceutical environment (e.g., cGXP) preferred.
• Ability to learn quickly and to tackle problems in a timely manner using analytical chemistry skills.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.