Research Associate I, R&D Charact

Job Summary

Research Associate II - Nitrosamines (Characterization Team)

Baxter Pharmaceuticals RD is seeking a highly motivated scientist with proven expertise in liquid chromatography and mass spectrometry to join its Characterization team. As a key contributor 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. The candidate is expected to work independently in the laboratory, to design studies, conduct independent experiments, and generate and interpret data to solve challenging analytical problems.

Responsibilities

• 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.

Qualifications / What you'll bring

• Masters degree with at least 6-10 years, or PhD 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 disciplines, such as chromatography, NMR, IR, etc. Advantage if possess skills, or demonstrated scientific background for the development of the necessary skills, for the elucidation of unknown compound structure using a multidisciplinary approach.
• Experience in Nitrosamine, EL 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.
• Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.
• Ability to make routine, and some less routine, decisions independently.
• Can effectively communicate 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.