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
Click here to apply (Insert official application link here)
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