Research Development Officer

Job Description: Formulation & Development Sterile
Department: Formulation & Development Location: Rabale

Key Responsibilities:

1. Sterile Formulation Development

Develop formulations for sterile dosage forms such as injectable solutions, suspensions, emulsions, lyophilized products, and ophthalmics.

Execute pre-formulation studies, compatibility studies, and stability studies.

Optimize formulas and processes to meet product quality, safety, and regulatory standards.

2. Aseptic Manufacturing Support

Work closely with production during scaling-up and pilot/batch manufacturing in aseptic areas.

Ensure adherence to aseptic processing guidelines and cleanroom behavior practices.

3. Process Development & Optimization

Conduct trials for process optimization, mixing strategies, filtration, sterilization cycles, and lyophilization parameters.

Prepare and review process development reports.

4. Documentation & Compliance

Prepare MFRs, BMRs, development reports, protocols, and SOPs.

Maintain compliance with cGMP, GLP, and company quality systems.

Support in preparation of regulatory documents (ANDA, DMF, CTD sections).

5. Stability Studies & Analytical Coordination

Design stability studies as per ICH guidelines.

Coordinate with QC/Analytical teams for method development, validation, and testing.

6. Technology Transfer

Participate in seamless technology transfer to manufacturing sites.

Prepare tech-transfer documents and support during exhibit batches.

7. Cross-Functional Collaboration

Work closely with QA, Production, Analytical R&D, Regulatory Affairs, and Procurement for smooth project execution.