Research Scientist I, R&D (Complex Injectables Analytics) – Baxter, Ahmedabad

Job Description

Baxter is hiring a Research Scientist I in R&D for its Global Pharmaceutical R&D Complex Product Development team in Ahmedabad. The scientist leads and executes analytical activities that support development of complex injectable products, including peptides and iron-based formulations.

The work spans analytical method development, validation, technology transfer, stability studies and regulatory support, in line with GxP, GDP and global quality standards. It is a role for experienced pharmaceutical analytical scientists.

Key Responsibilities

• Execute analytical method development, pre-validation, validation and technology transfer for complex injectable drug products.
• Test and characterize APIs, drug products, stability samples, development and validation batches, and reference listed drugs (RLDs).
• Support regulatory submissions by generating analytical data and responding to regulatory queries.
• Develop and review analytical reports, SOPs, methods of analysis and protocols.
• Conduct investigations related to OOS, OOT, deviations and non-conformances.
• Operate, review calibration of, qualify and troubleshoot analytical instruments.
• Record data accurately in ELN and comply with GxP, GDP, ALCOA++, ICH and pharmacopoeial requirements.
• Review stability programs and qualification documents, manage API and excipient vendor approvals and review Drug Master Files (DMFs).
• Coordinate with cross-functional teams, contract manufacturing sites, suppliers and global stakeholders.

Qualifications

• Master's degree with at least 5–8 years of experience, or a PhD with 4–6 years, in a relevant discipline.

Experience

Significant experience in pharmaceutical analytical development for complex injectables, sterile products or parenteral formulations, including regulatory submissions for global markets.

Skills Required

• Analytical method development, validation, technology transfer and stability studies
• Peptide and iron colloidal drug product analysis
• Particle size techniques: gel filtration chromatography, light scattering, diffraction, obscuration
• Iron speciation assays (ferrous, ferric, labile iron, chelation, reduction potential, kinetics)
• ICH guidelines, pharmacopoeial requirements, GLP, GDP and GxP
• Laboratory systems such as ELN, TrackWise and TCU

Additional Information

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