Research Associate II, stability

Baxter Healthcare; India; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Baxter Healthcare is seeking an experienced stability studies lead in India to design and execute stability programs for new product development and sustaining initiatives. You will provide scientific and regulatory guidance, ensuring compliance with global requirements and project timelines.

Collaborate with QA, QC, Regulatory Affairs, Manufacturing and R&D teams, manage multiple projects, and drive continuous improvement using LIMS and electronic stability systems.

Qualifications

• > Must have strong knowledge of stability study design, execution, and data interpretation.
• > Experience with ICH Stability Guidelines, cGxP, QSRs and global regulatory expectations.
• > Excellent technical writing and regulatory documentation skills.

Responsibilities

• Develop and execute stability study designs for new product development and sustaining projects.
• Provide scientific justification for shelf-life, expiration dating, and storage condition recommendations.
• Lead stability-related technical investigations and analytical problem solving.
• Prepare and support regulatory submissions and responses to health authority inquiries.
• Ensure compliance with ICH stability guidelines, cGxP, QSRs, and internal quality requirements.
• Collaborate with QA, QC, Regulatory Affairs, Manufacturing, and R&D teams to support project objectives.
• Utilize LIMS and electronic stability systems for protocol creation and study management.
• Drive continuous improvement, innovation, and operational excellence initiatives.
• Develop and implement SOPs, scientific procedures, and best practices.
• Independently manage multiple stability projects and deliverables within established timelines.

Skills

Stability studies

Pharma product development

Regulatory compliance

Data interpretation

Scientific writing

Stakeholder management

Cross-functional collaboration

Process improvement

Education

M.Pharm or equivalent

Tools

LIMS

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.

Your Role at Baxter:

At Baxter, you will lead the design and execution of stability studies supporting new product development and sustaining product initiatives. You will provide scientific and regulatory guidance for stability programs, including shelf-life and storage condition recommendations. Working closely with cross-functional teams, you will ensure compliance with global regulatory requirements and project timelines.

What you'll be doing:

• Develop and execute stability study designs for new product development and sustaining product projects.
• Provide scientific justification for shelf-life, expiration dating, and storage condition recommendations.
• Lead stability-related technical investigations and analytical problem-solving activities.
• Prepare and support regulatory submissions and responses to health authority inquiries.
• Ensure compliance with ICH (International Council for Harmonisation) stability guidelines, cGxP, QSRs, and internal quality requirements.
• Collaborate with QA, QC, Regulatory Affairs, Manufacturing, and R&D teams to support project objectives.
• Utilize LIMS and electronic stability systems for protocol creation and study management.
• Drive continuous improvement, innovation, and operational excellence initiatives.
• Develop and implement SOPs, scientific procedures, and best practices.
• Independently manage multiple stability projects and deliverables within established timelines.

What you'll bring:

• M.Pharm or equivalent degree in Pharmaceutical Sciences or related discipline.
• 8+ years of experience in Stability Studies, Pharmaceutical Product Development, or related R&D functions.
• Strong knowledge of stability study design, execution, and data interpretation.
• In-depth understanding of ICH Stability Guidelines, cGxP requirements, QSRs, and global regulatory expectations.
• Experience supporting expiration dating, shelf-life determination, and storage condition recommendations.
• Hands-on experience with LIMS and electronic stability management systems.
• Strong analytical and scientific problem-solving skills.
• Ability to independently manage complex technical projects.
• Excellent technical writing and regulatory documentation skills.
• Effective stakeholder management and cross-functional collaboration abilities.
• Demonstrated capability to influence technical decisions and drive process improvements.
• Experience with global regulatory submissions and health authority interactions.
• Experience leading operational excellence and continuous improvement initiatives.
• Broad understanding of pharmaceutical development, manufacturing, and quality 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.

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