Position Summary
Responsible for development of injectable formulations for regulated markets (US & EU). The role includes formulation design, optimization, regulatory documentation support, scale-up, technology transfer, and identification of current product opportunities including 505(b)(2) pathways.
Key Responsibilities
- Develop solution, suspension, lyophilized injections, and pre-filled syringes (PFS).
- Conduct pre-formulation studies, excipient screening, and compatibility and stability studies.
- Literature Search, Report Preparations, advanced characterization interpretations.
- Optimize formulations using QbD principles and Design of Experiments (DoE).
- Develop lyophilization cycles and evaluate container-closure systems.
- Prepare lab and pilot-scale batches; troubleshoot formulation issues.
- Support ANDA, EU dossier and 505(b)(2) submissions; prepare CTD Module 3 (3.2.P) documentation.
- Ensure compliance with ICH guidelines and USFDA/EMA regulatory requirements.
- Support technology transfer, scale-up, validation batches and stability studies.
- Coordinate with QA, QC,



Production and Regulatory teams for project execution.
- Maintain development reports, documentation and support audits/inspections.

Technical Competencies
- Hands-on experience in injectable formulation development and Equipment such as HPH, TFF, Extruder, Milling, Rota, ANFD, Mixing equipment’s, High sheer mixers, Lyophilizers Spray dryer, TFE
- Knowledge of aseptic processing, sterile filtration and autoclave sterilization.
- Understanding of extractables & leachables, particulate control and CCIT.
- Strong scientific writing, analytical interpretation and problem-solving skills.
- Exposure to oncology, hormonal, high-potent or complex injectables (preferred).

Key Performance Indicators (KPIs)
- Timely completion of development milestones.
- Successful scale-up and regulatory documentation readiness.
- Contribution to innovative 505(b)(2) and differentiated product pipeline.
- Complia

📌 Senior Officer/Officer (Baska)
🏢 BDR GROUP
📍 Baska