Research Scientist I, Research & Development,
Baxter International Inc.
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.
Your Role at Baxter
As a member of the Global Pharmaceutical Research & Development (GPRD) Complex Product Development team, you will lead and execute analytical activities supporting the development of complex injectable products, including peptide and iron-based formulations. You will be responsible for analytical method development, method validation, technology transfer, stability studies, and regulatory support, while ensuring compliance with Good "x" Practice (GxP), Good Documentation Practices (GDP), and global quality standards. This role is critical in supporting product development, regulatory submissions, and lifecycle management across Baxter's global portfolio.
What You'll Be Doing
- Execute analytical method development, method pre-validation, method validation, and technology transfer activities for complex injectable drug products.
- Perform testing and characterization of Active Pharmaceutical Ingredients (APIs), drug products, stability samples, development batches, validation batches, and Reference Listed Drugs (RLDs).
- Support regulatory submissions by generating analytical data and responding to regulatory agency queries.
- Develop, review, and maintain analytical reports, Standard Operating Procedures (SOPs), MOAs Methods of Analysis (MOAs), study protocols, and laboratory documentation.
- Conduct analytical investigations related to Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, deviations, non-conformances, and laboratory investigations.
- Perform routine operation, calibration review, qualification support, maintenance coordination, and troubleshooting of analytical instruments.
- Execute, interpret, and document complex analytical techniques relevant to peptide and iron colloidal drug products.
- Support preventive maintenance activities, risk assessments, investigations, and Corrective and Preventive Actions (CAPAs) for laboratory equipment and systems.
- Ensure accurate data recording in Electronic Laboratory Notebook (ELN) and compliance with Good "x" Practice (GxP), Good Documentation Practices (GDP), Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA++), International Council for Harmonization (ICH) Guidelines, and pharmacopeial requirements.
- Review stability protocols and reports, qualification documents, data logger reports, and vendor-supplied documentation.
- Manage Active Pharmaceutical Ingredient (API) and excipient vendor qualification and approval activities, including the review of Drug Master Files (DMFs)
- Collaborate with cross-functional teams, contract manufacturing organizations (CMOs), suppliers, and global stakeholders to ensure project milestones and timelines are achieved.
- Master's Degree 5 to 8 years of relevant work experience, OR Doctor of Philosophy (PhD) 4 to 6 years of relevant work experience.
- Significant experience in pharmaceutical analytical development within complex injectables, sterile products, or parenteral formulations.
- Hands-on expertise in analytical method development, validation, technology transfer, and stability studies.
- Experience supporting regulatory submissions for global markets.
- Strong experience with peptide and iron colloidal drug product analysis.
- Knowledge of particle size distribution techniques including Gel Filtration Chromatography (GFC), light scattering, diffraction, and obscuration methods.
- Experience with iron speciation assays including ferrous, ferric, labile iron, chelation assays, reduction potential, and kinetics studies.
- Working knowledge of analytical techniques used for complex injectable products.
- Strong understanding of ICH Guidelines, pharmacopeial requirements, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and GxP regulations.
- Experience using laboratory electronic systems such as ELN, Track Wise, Temperature Control Unit (TCU), and related quality management systems.
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.
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