About This Role
This role involves initiating and overseeing projects within the Product Development (PD) lab, focusing on all activities from initial concept to commercialization. The scientist ensures all documentation for tech transfer and Standard Operating Procedures (SOPs) is in place, conducts laboratory trials, and provides training and supervision to Research Associates in product development and documentation.
Responsibilities
- Understand project timelines and required activities for timely execution
- Perform literature searches for Idea Generation Forms (IGF)
- Review Drug Master Files (DMF) from suppliers
- Prepare product feasibility reports based on IGF received
- Create item codes for materials and procure materials and Reference Listed Drug (RLD)
- Assist AD lab for Q1 Q2 estimation of RLD
- Draft tentative specifications for API, raw materials, and finished goods
- Plan laboratory trials and stability batches
- Finalize proposed manufacturing processes
- Initiate filter validation processes with filter suppliers
- Operate Bead mills and high-pressure homogenizers
- Prepare tech transfer documents including Manufacturing Formula Records (MFR), Bill of Materials (BOM), process flowcharts, critical process parameters, and critical quality activities
- Review product specifications and manufacturing documents
- Prepare documents for trial batches
- Prepare product development reports
- Prepare and review SOPs and prepare responses for internal audits
- Review documents related to filter validation
- Organize and execute trial pre-exhibit and exhibit batches at the plant
- Execute first three commercial batches at the plant
- Provide technical support for existing commercial batches
- Perform investigations of failures during exhibit batches/stability (Out of Specification)
- Propose innovative and patentable formulations
- Propose novel ideas to reduce workload or expenses
- Mentor Research Associates (RAs) in planning project activities in minute and actionable details
- Help RAs in carrying out literature searches
- Help RAs in procuring RLD, API, and excipients
- Plan and execute knowledge-sharing sessions for compatibility studies, reverse engineering, laboratory batch planning, filter compatibility, process optimization, and recent field updates to emphasize timeline adherence to team members
Requirements
- Experience in Bead mill and High Pressure Homogenizer operations
Important Details
- Team: Train, mentor and supervise Research Associates
