- Formulation R&D product development with a focus on injectable product development.
- Experience with Novel Drug Delivery Systems, Lyophilized products, and Solution products.
Key Responsibilities:
- Literature Search: Conduct Summary Based Approval (SBA), Patent reviews, and research article searches relevant to project requirements, understanding regulatory guidance.
- Experimental Design: Design and conduct pre-formulation and formulation developmental experiments using Quality by Design (QbD) approach. Record drug product manufacturing experiment details in Laboratory notebooks.
- Documentation: Prepare product development protocols, stability study protocols, and reports. Draft Standard Operating Procedures (SOPs) for laboratory equipment/instruments. Maintain critical data records for regulatory audits.
- Technology Transfer: Create documents for technology transfer including Master Formula, Risk Assessment, Failure Mode Effect Analysis, and Safety Data Sheets.
- Cross-functional Support: Assist with cross-functional activities at the plant for Scale-up, Exhibit batches, and Commercial batches for assigned projects.
- Report Compilation: Prepare Product Development Reports (PDR), Risk Assessment Reports, and compile various project reports.