Research Associate I - R&D, Complex Product Development

Responsibilities

• Perform advanced characterization of complex injectable drugs, including proteins, peptides, and oligonucleotides, for regulatory submissions.
• Execute method development, method qualification, sameness studies, and routine analysis following GLP norms.
• 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 to cross-functional teams and Baxter Global sites.
• Maintain rigorous documentation according to ALCOA++ principles, Good Documentation Practices (GDP), and approved SOPs.
• Oversee instrument operation, calibration, and preventive maintenance for spectroscopic and biophysical equipment.
• Support procurement activities by reviewing quotations and engaging suppliers for required goods and services.

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 the acquisition, processing, and data analysis of CD, FTIR, and fluorescence spectroscopy.
• Strong knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Proficiency in spectroscopic and biophysical methods for the analysis of proteins and peptides.
• Ability to travel to external facilities and CROs as required.

Preferred Qualifications

• Expertise in computational chemistry, molecular modeling, and statistical methods.
• Understanding of liquid chromatographic methods, dynamic light scattering, AF4-MALS, and SV-AUC.
• Experience with NMR instrument operation and troubleshooting.
• Proficiency in literature searches through scientific databases like PubMed.
• Knowledge of ICH Guidelines and pharmacopoeia implementation.

About the Company

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