Research Associate I, R&D Complex Product Development

Responsibilities

• Execute advanced characterization studies for complex injectable drugs, including iron formulations, proteins, peptides, and oligonucleotides.
• Perform method development, method qualification, sameness studies, and routine analysis for regulatory submissions.
• Manage outsourced studies at CROs and academic institutes, including study design, execution, and report preparation.
• Act as a Subject Matter Expert (SME) to provide analytical support and overcome technical challenges in product development.
• Maintain strict adherence to GLP, Good Documentation Practices, and ALCOA++ principles.
• Operate, calibrate, and perform preventive maintenance on laboratory instrumentation.
• Prepare and update SOPs, method development reports, and verification reports.

Requirements

• Masters in Pharmacy or an equivalent discipline with 6–10 years of relevant experience, OR a PhD in biophysics, biochemistry, or an equivalent discipline with 0–5 years of experience.
• Mandatory expertise in SEC-UV-MALS and related methods, including liquid chromatography, light scattering, diffraction, and light obscuration.
• Strong proficiency in biophysical and spectroscopic methods (e.g., CD, FTIR, UV, EPR, Mossbauer, or fluorescence spectroscopy).
• Deep knowledge of GLP, Good Documentation Practices, and ICH Guidelines.
• Ability to perform literature searches through scientific databases and patent repositories.

Preferred Qualifications

• Expertise in computational chemistry, molecular modeling, and statistical methods.
• Experience with particle XRD, microscopy methods (AFM & EM), and related orthogonal methods.
• Experience in the operation and maintenance of NMR instrumentation.

About the Company

Baxter is a global healthcare leader dedicated to a mission to save and sustain lives. Since 1931, we have been at the forefront of medical innovation, redefining healthcare delivery to make a greater impact on patients around the world through smarter, more personalized care.