Assistant Manager-Formulation Development(Injectables)

We are looking for an experienced Assistant Manager Formulation & Development (Injectables) to join our R&D team at Andheri (East), Mumbai. The candidate should have hands-on experience in the development of sterile injectable formulations and exposure to product development from laboratory scale through scale-up and technology transfer.

Key Responsibilities:

• Develop sterile injectable formulations including Solutions, Lyophilized Products, Emulsions and Suspensions.
• Conduct pre-formulation studies, compatibility studies, excipient selection and formulation optimization.
• Support and monitor manufacturing, filtration, filling and aseptic processes.
• Work on lyophilization cycle development and optimization.
• Handle process development, scale-up and technology transfer from laboratory to pilot/commercial manufacturing.
• Support execution and monitoring of exhibit batches.
• Prepare/review technical documentation including Product Development Reports (PDR), Master Formula Records (MFR) and CMC-related documentation.
• Coordinate with Analytical, Quality, Regulatory, Production and Purchase teams for timely project execution.
• Investigate and troubleshoot formulation and process-related issues, including deviations and CAPA.
• Ensure development activities are carried out in accordance with applicable ICH, cGMP and regulatory requirements.

Qualification: M.Pharm in Pharmaceutics/Pharmaceutical Sciences or relevant specialization.

Experience: Candidates should have relevant hands-on experience in Formulation & Development of Injectable/Sterile Dosage Forms, particularly aseptic processing and lyophilization. Knowledge of ICH guidelines, cGMP and USFDA/EMA/CDSCO requirements will be preferred.

Key Skills: Injectable Formulation Development | Sterile Products | Lyophilization | Aseptic Processing | Scale-Up | Technology Transfer | Exhibit Batches | PDR/MFR | CMC Documentation | Troubleshooting

Interested candidates may share their updated CV mentioning Current CTC, Expected CTC and Notice Period. email your resume to [email removed],[email removed]