Research Associate I, R&D – F&D at Baxter

Baxter, a global leader in healthcare solutions, is hiring a Research Associate I in R&D – F&D at its Ahmedabad location. This role is ideal for M.Pharmacy and Ph.D graduates looking to contribute to the development of injectable pharmaceutical products. If you are passionate about drug development, regulatory compliance, and lab research, this position offers the opportunity to work on ANDA injectable products while collaborating with cross-functional teams.

Key Responsibilities

• Conduct technical feasibility experiments for new projects.
• Initiate resource procurement for R&D activities.
• Execute developmental trials, PDR studies, and QBD studies for ANDA injectable products.
• Compile developmental data and prepare technical documents like MFR, PDR, protocols, and reports.
• Coordinate with CFT teams (ADL, IRA, Procurement, Quality) to ensure timely resource availability.
• Oversee Exhibit batch production at Baxter and CMO sites.
• Review raw materials, packing materials, and commercial product specifications.
• Perform remediation trials based on regulatory commitments, OOS, CAPA, and product nature.
• Support regulatory queries and prepare reports for submission.
• Manage lab equipment, documentation, and warehouse entries as per SOPs; revise SOPs when needed.
• Identify and request new equipment/instruments for ongoing projects and continuous lab improvements.
• Adopt GQP procedures, TcU, and PDLM (Product Development Life Cycle Management).

Qualifications

• Education: M.Pharmacy or Ph.D in relevant pharmaceutical disciplines.
• Strong understanding of ANDA injectable product development, lab experiments, and regulatory submissions.
• Familiarity with SOPs, GQP, PDLM, and lab instrumentation.
• Excellent coordination and teamwork skills to interact with cross-functional teams.

Benefits

• Work with a global healthcare leader dedicated to saving and sustaining lives.
• Exposure to ANDA injectable development projects and regulatory compliance.
• Opportunity for career growth and skill development in pharmaceutical R&D.
• Inclusive work culture supporting diversity, equity, and accommodations.

How to Apply

Application Link