13 Aug
|
OFF Targets Research
|
Bengaluru
13 Aug
OFF Targets Research
Bengaluru
Role & responsibilities
Position Summary
Off Targets Research is seeking a technically robust Team Leader / Head Formulation Development (Injectables) to lead the formulation development section within our Injectable R&D; function. This role owns hands-on formulation and process development for differentiated injectable products — solutions, suspensions, emulsions, lyophilized products, depot/long-acting injectables, and other sterile dosage forms — from early feasibility through scale-up and technology transfer.
This is a section-head level role for a hands-on formulator with strong technical depth, who can lead a small team of scientists, manage day-to-day development execution, and ensure formulation deliverables are met on time and to the quality standard required for regulatory submission and technology transfer.
Key Responsibilities
- Lead formulation development activities for assigned injectable programs, from preformulation and prototype development through optimization, scale-up, and exhibit batch support.
- Independently drive development of complex injectable formulations, including suspensions, emulsions, RTU products, lyophilized products, and other differentiated sterile systems.
- Plan and execute compatibility studies, excipient screening, container closure evaluation, and process parameter optimization.
- Apply QbD principles and risk-based approaches to formulation design and troubleshooting.
- Coordinate closely with Analytical R&D; for method alignment, characterization, and stability study execution.
- Troubleshoot formulation and process issues such as stability failures, precipitation, particle size drift, syringeability/injectability concerns, reconstitution behavior, and process robustness gaps.
- Prepare and review development reports, protocols, specifications, and technology transfer documentation.
- Support technology transfer to pilot/manufacturing sites and provide technical input during scale-up and exhibit batch manufacturing.
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📌 Team Leader R&D Injectable Products (Bengaluru)
🏢 OFF Targets Research
📍 Bengaluru