Research Scientist I Research And Development

Baxter International Inc.; Ahmedabad District; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

At Baxter, we are redefining healthcare with a mission to save and sustain lives. The Global Pharmaceutical R&D team seeks an experienced analytical scientist to lead development and validation of complex injectable products, including peptides and iron-based formulations.

You will perform method development, validation, tech transfer, stability studies, and regulatory support, ensuring GxP compliance and ALCOA++ data integrity across global submissions.

Qualifications

• Masters degree with at least 5-8 years, or PhD with 4-6 years in relevant discipline required.
• Extensive 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.

Responsibilities

• Execute analytical method development, pre-validation, validation, and technology transfer activities for complex injectable drug products.
• Perform testing and characterization of 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 queries.
• Develop and review analytical reports, SOPs, MOAs, protocols, and laboratory documentation.
• Conduct analytical investigations related to OOS, OOT, deviations, non-conformances, and laboratory abnormalities.

Skills

Analytical method development

Technology transfer

Regulatory submissions support

GxP knowledge

Education

Master's degree in a relevant discipline

PhD in a relevant discipline

Tools

ELN

TrackWise

LIMS

QMS

Job description

Job Description:

This is whereyour work makes a difference.

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.

Role at Baxter:

As a member of the Global Pharmaceutical R&D (GPRD) Complex Product Development team, you will lead and execute analytical activities supporting the development of complex injectable products, including peptides and iron-based formulations. You will be responsible for analytical method development, validation, technology transfer, stability studies, and regulatory support while ensuring compliance with GxP (Good “x” Practice), GDP (Good Documentation Practices) and global quality standards. This role is critical in driving product development, regulatory submissions, and lifecycle management across Baxter's global portfolio.

What You'll Be Doing:

• Execute analytical method development, pre-validation, validation, and technology transfer activities for complex injectable drug products.
• Perform testing and characterization of 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 queries.
• Develop and review analytical reports, SOPs (Standard Operating Procedures), methods of analysis (MOAs), protocols, and laboratory documentation.
• Conduct analytical investigations related to OOS, OOT, deviations, non-conformances, and laboratory abnormalities.
• Perform routine operation, calibration review, qualification support, and troubleshooting of analytical instruments.
• Execute and interpret complex analytical techniques relevant to peptides and iron colloidal drug products.
• Support preventive maintenance, risk assessments, and corrective actions for laboratory equipment and systems.
• Ensure accurate data recording in ELN and compliance with GxP, GDP, ALCOA++, ICH guidelines, and pharmacopoeial requirements.
• Review stability programs, qualification documents, data logger reports, and vendor documentation.
• Manage API and excipient vendor approval activities and review Drug Master Files (DMFs).
• Coordinate with cross-functional teams, contract manufacturing sites, suppliers, and global stakeholders to meet project timelines.

What You'll Bring:

• Masters degree with at least 5-8 years, or PhD with 4-6 years in relevant discipline required.

• 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, pharmacopoeial requirements, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and GxP regulations.
• Experience using laboratory electronic systems such as ELN, TrackWise, TCU, and related quality management systems.

Equal Employment Opportunity

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, let us know the nature of your request along with your contact information.