Research Associate I/II – R&D Characterization
Department: Research & Development – Characterization
Organization: Baxter Pharmaceuticals R&D
Focus Area: Nitrosamines, LC-MS/GC-MS, Extractables & Leachables
Position Overview
Baxter Pharmaceuticals R&D is seeking a highly motivated and experienced scientist to join its Characterization team within the Pharmaceuticals Global Business Unit.
The role focuses on the application of advanced mass spectrometry and chromatography-based technologies to support the development and characterization of new and existing pharmaceutical products.
The successful candidate will primarily support nitrosamine studies, along with extractables and leachables (E&L) investigations. Responsibilities include identifying nitrosamines and potential leachable compounds, developing and validating analytical methods, conducting laboratory studies, and interpreting complex analytical data.
The position requires an individual who can work independently, design and execute experiments, solve challenging analytical problems, and communicate scientific findings effectively.
Key Responsibilities
Nitrosamine and Analytical Method Development
Develop, validate, and transfer quantitative analytical methods for nitrosamine impurities, including small-molecule nitrosamines and N-nitrosamine drug substance-related impurities (NDSRIs).
Develop methods capable of detecting and quantifying impurities from ppm to sub-ppb levels.
Design and conduct experiments to identify the root causes of nitrosamine formation.
Support the development and implementation of strategies to mitigate nitrosamine impurities.
Develop and validate novel mass spectrometry-based analytical methods.
Perform complex quantitative LC/MS method development and validation.
Mass Spectrometry and Laboratory Studies
Apply advanced LC-MS and GC-MS technologies to address complex analytical challenges.
Conduct sophisticated mass spectrometric experiments, including accurate-mass analysis and MS/MS.
Interpret complex mass spectrometry data to identify and characterize unknown compounds.
Perform chemical extractions of container closure systems and pharmaceutical drug product solutions.
Support extractables and leachables studies using mass spectrometry-based analytical approaches.
Apply multidisciplinary analytical techniques, including chromatography, NMR, IR, and organic chemistry, for compound identification and structural elucidation.
Research and Project Management
Design experiments and develop appropriate analytical strategies for assigned projects.
Independently plan, execute, and manage laboratory studies.
Work with subject matter experts and supervisors to manage projects involving multiple disciplines.
Assess technical feasibility of complex analytical concepts and provide recommendations to management.
Interpret analytical data and identify trends, exceptions, and results relative to product requirements and project objectives.
Draw scientifically sound conclusions from research and incorporate recommendations into broader projects.
Share research findings, methodologies, and technical knowledge with team members and other internal stakeholders.
Quality and Regulatory Compliance
Maintain current knowledge of applicable Quality System Regulations and regulatory requirements relevant to pharmaceutical R&D.
Ensure compliance in research activities, data collection, documentation, and reporting.
Maintain strong knowledge of GxP requirements and relevant regulatory guidance.
Provide scientific and regulatory insights to support efficient product registration.
Participate in the review, interpretation, and implementation of applicable regulations and guidelines.
Collaboration and Leadership
Communicate effectively with internal and external stakeholders and project partners.
Translate strategic direction and technical objectives into actionable plans.
Provide guidance and technical expertise to junior associates.
Make routine and selected non-routine decisions independently.
Contribute to a collaborative, innovative, and results-oriented R&D environment.
Required Qualifications
Master's degree with 6–10 years of relevant experience, or
PhD with 4–6 years of relevant experience.
Relevant educational background in analytical chemistry, pharmaceutical sciences, chemistry, or a related scientific discipline.
Formal training and strong practical expertise in mass spectrometry.
Demonstrated ability to perform advanced mass spectrometric experiments, including accurate mass and MS/MS.
Strong ability to interpret mass spectrometric data.
Good knowledge of organic chemistry and analytical techniques.
Experience with chromatography and other analytical techniques such as NMR and IR.
Preferred Experience
Experience with nitrosamine testing and characterization.
Experience in extractables and leachables (E&L) testing and study design.
Experience in environmental chemistry testing or trace organic analysis.
Experience with complex analytical method development and validation.
Strong experience developing quantitative LC/MS methods.
Experience working in a regulated pharmaceutical environment, preferably under cGXP requirements.
Demonstrated ability to identify and elucidate unknown compounds using multidisciplinary analytical approaches.
Key Competencies
Strong analytical and problem-solving skills.
Ability to independently design and execute scientific experiments.
Ability to interpret complex analytical data and draw meaningful conclusions.
Strong understanding of analytical chemistry principles.
Ability to learn new technologies and methodologies quickly.
Ability to manage projects and meet timelines.
Strong written and verbal communication skills.
Ability to collaborate effectively with internal and external partners.
Ability to make independent technical decisions.
Ability to mentor and provide technical direction to junior team members.
About Baxter
Baxter is committed to advancing healthcare and improving patient outcomes through innovative products, technologies, and solutions. Its Research and Development teams work collaboratively across scientific and engineering disciplines to develop products and technologies that help save and sustain lives.
Baxter promotes a culture built around courage, trust, collaboration, innovation, accountability, and meaningful contribution.
Employee Benefits
Support for parents.
Continuing education and professional development opportunities.
Employee health and well-being benefits.
Paid time off.
Two paid days per year for volunteering.
Equal Employment Opportunity
Baxter is an equal opportunity employer and evaluates qualified candidates without regard to legally protected characteristics, in accordance with applicable laws and regulations.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities throughout the recruitment and interview process. Candidates requiring an accommodation can contact Baxter through its designated accommodation process.
Recruitment Fraud Awareness
Baxter advises job seekers to remain alert to employment scams involving individuals falsely claiming to represent Baxter. Candidates should be cautious when asked to provide personal, confidential, or financial information during the recruitment process.
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