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Research Associate Ii – R&D, Stability Studies

13 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Research Associate II – R&D, Stability Studies
Job Requisition Number: JR-178110
Location: Ahmedabad, Gujarat, India
Company: Baxter International Inc.


About Baxter

At Baxter, our mission to Save and Sustain Lives drives everything we do. For over 85 years, our products and therapies have been vital in hospitals, clinics, and homes around the world. We foster a culture where every individual feels purpose, contributes to healthcare innovation, and is empowered to make an impact.


Position Summary

As a Research Associate II in the Stability Studies team, you will be responsible for planning, designing, executing, and managing stability studies for both new product development and sustaining projects. You will ensure scientific rigor, regulatory compliance (ICH/cGxP), and on-time delivery of critical documentation while collaborating with cross-functional teams globally.


Key Responsibilities

Stability Study Design & Execution

  • Independently design and plan stability studies for injectable and solid dosage forms.

  • Evaluate and recommend technical approaches for expiration dating and label storage statements.

  • Utilize LIMS systems to initiate and manage electronic stability protocols.

  • Conduct photostability, in-use, and freeze-thaw studies.

Technical & Regulatory Support

  • Prepare regulatory documentation, respond to regulatory queries, and ensure compliance with ICH, cGMP, cGLP, and internal guidelines.

  • Review and analyze stability data against product specifications and regulatory requirements.

  • Assist in analytical problem-solving, method transfer, validation, and equivalency testing.

  • Participate in internal and external audits; address audit findings and implement corrective actions.

Documentation & Quality Assurance

  • Author and review protocols, reports, and SOPs related to stability studies.

  • Maintain stability chambers, documentation logs, and ensure audit readiness.

  • Handle and document OOS/OOT investigations, deviations, and change controls.

  • Use EDMS (Documentum) and LabVantage LIMS for document and data management.

Cross-functional Collaboration

  • Work closely with QA, QC, Regulatory Affairs, Manufacturing, PM, IT, and CROs to ensure project alignment.

  • Lead the harmonization of stability practices across Baxter and partner sites.

  • Coordinate activities to ensure organizational and project-specific goals are achieved.

Team Leadership & Training

  • Provide training on analytical techniques, LIMS usage, and documentation processes.

  • Supervise junior team members; conduct performance evaluations and feedback sessions.

  • Ensure KPI/KQI metrics are tracked and maintained for stability functions.


Required Qualifications

  • Master’s Degree in Pharmaceutical Sciences or related field

  • Minimum 13 years of GxP laboratory experience in:

    • Stability studies

    • Analytical method development, validation, and transfer

    • Regulatory submissions and audit handling


Preferred Skills & Competencies

  • Deep understanding of ICH stability guidelines, cGMP, and quality systems

  • Experience with LIMS (LabVantage), EDMS (Documentum), and regulatory documentation

  • Strong analytical, problem-solving, and project management skills

  • Excellent oral and written communication

  • Ability to lead innovation and continuous improvement initiatives

  • Collaborative mindset with experience in cross-functional and global team environments


Baxter Benefits & Culture

  • Paid Time Off

  • 2 Days Annually for Volunteering

  • Continuing Education & Professional Development

  • Health & Well-being Benefits

  • Parental Support Programs

  • Inclusive and Innovation-driven Culture


Equal Opportunity Statement

Baxter is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity/expression, disability, or veteran status.


Recruitment Fraud Notice

Beware of recruitment scams. Baxter does not request sensitive personal or financial information during the hiring process. Visit our official Recruitment Fraud Notice for more information.


Office Location

Baxter – Ahmedabad Office
Navratna Corporate Park

  • Tower A, Ground Floor

  • Tower B, 21st and 22nd Floors
    Gujarat – 380058, India


Apply Now

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