Research Associate I RandD Charact

Baxter International Inc.; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Baxter International Inc. is seeking a Research Associate II – Nitrosamines (Characterization Team) to join its R&D group.

The role focuses on developing LC-MS/GC-MS methods to quantify Nitrosamine impurities and leachables in drug products, while designing experiments to identify root causes and mitigation strategies. The successful candidate will work independently in the lab, design studies, conduct experiments, and interpret data to support nitrosamines studies and related regulatory

Qualifications

• Must have formal training in mass spectrometry and be skilled in MS, accurate mass and MS/MS interpretation.
• Knowledge of organic chemistry and analytical disciplines (chromatography, NMR, IR).
• Experience with Nitrosamine, E&L testing/study design or trace organic analysis preferred.
• Experience with method development and validation for quantitative LC/MS methods.

Responsibilities

• Develop, validate and transfer methods for quantifying Nitrosamine impurities (ppm to ppb).
• Design experiments to identify root causes of Nitrosamine formation and mitigation strategies.
• Perform chemical extractions of container closure systems and drug product solutions.
• Apply MS-based approaches to develop and validate novel analytical methods.
• Plan, execute and manage projects spanning multiple disciplines and established methods.
• Propose technical feasibility and advise management on actions.
• Interpret data and evaluate results relative to product requirements and goals.
• Share research outcomes with team and other divisions.
• Maintain knowledge of Quality System Regulations and regulatory requirements for R&D data and reporting.

Skills

Mass spectrometry

LC-MS

GC-MS

Chromatography

MS/MS interpretation

Education

Master's degree with 6–10 years

PhD with 4–6 years

Tools

NMR

IR spectroscopy

HPLC

Job description

Job Description:

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

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 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.

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 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.

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, 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.
• 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.

Equal Employment Opportunity

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.

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.