Posted:1 hour ago|
Platform:
Work from Office
Full Time
Senior Scientist with expertise in oral liquid formulation development, manufacturing, and regulatory compliance, driving innovation and quality in pharmaceutical product development.
With a passion about formulation and development for oral liquid.
- Design, develop, and optimize oral liquid formulations for new and existing products.
- Conduct pre-formulation studies, solubility testing, and stability assessments.
- Lead cross-functional teams to develop and launch new oral liquid products.
- Collaborate with R&D, Quality, and Manufacturing teams to ensure smooth technology transfer.
- Develop and implement product development plans, timelines, and budgets.
- Ensure compliance with regulatory requirements, guidelines, and standards (e.g., USP, EP, JP).
- Prepare and review regulatory documents, including DMFs, ANDAs, and NDAs.
- Collaborate with regulatory teams to address regulatory queries and issues.
- Optimize manufacturing processes for oral liquid products, including mixing, filling, and packaging.
- Identify and implement process improvements to enhance efficiency, quality, and yield.
- Develop and implement process controls, including in-process testing and release criteria.
- Provide technical support to manufacturing, quality, and regulatory teams.
- Troubleshoot technical issues and provide solutions to ensure product quality and compliance.
- Conduct training and knowledge-sharing sessions to enhance team capabilities.
- Identify opportunities for innovation and continuous improvement in oral liquid formulation and development. - Evaluate and implement new technologies, processes, and methodologies to enhance product quality, efficiency, and competitiveness.
Mendine Pharmaceuticals
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