✨ AI Summary
The R&D Specialist will be responsible for conducting pre-formulation and formulation trials for MOH products, and optimizing existing commercial formulas. This role involves overseeing scale-up and pilot batch manufacturing, monitoring technology transfer, and preparing product development reports and master formula cards. The specialist will ensure adherence to GMP guidelines, author SOPs, analyze test result variances, and provide troubleshooting solutions for production. Additionally, they will operate R&D instruments, maintain MSDS files, and participate in EHS activities, including training new employees.
Requirements
Bachelor’s degree in pharmacy or a related field 2–5 years of experience in Research & Development within the pharmaceutical or related industries Good knowledge of GMP standards
Description
Formulation & Development: Conduct pre-formulation and formulation trials for MOH products, while optimizing existing commercial formulas when required.Scale-Up & Pilot Batches: Oversee the scaling-up process to production and lead the manufacturing of pilot batches (internally and externally).Technology Transfer: Monitor the Technology Transfer process with QA and Production, and execute consecutive validation/site transfer batches.Documentation & Reporting: Prepare Product Development Reports, Master Formula/Packaging Cards, and document all trial results and manufacturing data.Compliance & SOPs: Ensure full adherence to GMP guidelines and quality policies, and author standard operating procedures (SOPs) for the R&D department.Analysis & Troubleshooting: Prepare samples for stability and bioequivalence testing, analyze test result variances, and provide troubleshooting solutions for production.Equipment & MSDS Management: Operate and qualify R&D instruments, while maintaining up-to-date Material Safety Data Sheet (MSDS) files.EHS & Team Support: Participate in job risk analysis, report workplace hazards/incidents, and train new employees on safe working instructions.