Research Scientist (NDDS - INJ)

Role & responsibilities

Formulation Development

• Develop and optimize sterile injectable formulations, including solutions, suspensions, emulsions, liposomes, nanoparticles, depot injections, microspheres, and other NDDS-based products.
• Conduct pre-formulation studies, excipient compatibility studies, and formulation screening.
• Design and execute product development strategies to achieve target product profiles.

Process Development & Scale-Up

• Develop robust manufacturing processes for injectable dosage forms.
• Coordinate scale-up batches, exhibit batches, and process validation activities.
• Support technology transfer activities from R&D to commercial manufacturing sites.

Analytical & Characterization Support

• Interpret formulation characterization data such as particle size, zeta potential, encapsulation efficiency, viscosity, osmolality, and stability data.
• Work closely with Analytical Development teams for method development and validation activities.

Regulatory & Documentation

• Prepare development reports, protocols, product development reports (PDR), risk assessments, and regulatory documents.
• Review CTD sections, QOS documents, and support regulatory submissions for USFDA, EMA, MHRA, Health Canada, and other global markets.
• Provide responses to regulatory deficiencies and audit observations.

Project Management

• Lead multiple development projects and ensure adherence to project timelines.
• Coordinate with Regulatory Affairs, Analytical Development, Manufacturing, QA, QC, Supply Chain, and Packaging Development teams.
• Track project milestones and provide periodic updates to management.

Stability & Lifecycle Management

• Evaluate stability data and support product shelf-life assignment.
• Investigate stability failures, deviations, OOS, and formulation-related issues.
• Support product improvement and lifecycle management activities.

Compliance

• Ensure adherence to cGMP, GLP, data integrity, and EHS requirements.
• Maintain laboratory documentation as per regulatory requirements.

Preferred candidate profile

Required Qualification

• M. Pharm / MS (Pharm) / Ph.D. in Pharmaceutics, Pharmaceutical Technology, NDDS, or related discipline.
• Strong knowledge of sterile injectable formulation development.

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Required Experience

• 7-10 years of relevant experience in NDDS Injectable Product Development.
• Experience in complex injectable platforms such as:
• Liposomal Injectables
• Long-Acting Injectables (LAI)
• Depot Formulations
• Nanoparticle-Based Injectables
• Microspheres
• Emulsions and Suspensions
• Lyophilized Injectables