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.
- Robust knowledge of sterile injectable formulation development.

;

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

📌 Research Scientist (NDDS - INJ) (Ahmedabad)
🏢 Intas
📍 Ahmedabad