Job Scope:

• Proactively and effectively lead R&D teams; formulators and R&D analysts, through the effective planning and execution of drug development process of immediate release and modified release tablet and capsule dosage form, and R&D initiatives.
• Ensure the project management in alignment with the established organizational objectives
• Develop robust formulations and processes, scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production and to QC department to meet timelines and within budgets.
• Review of batch records, process characterization reports, validation reports and investigation reports.
• Effectively action and making decisions including issue managements for all R&D activities throughout scientific disciplines.
• Work collaboratively with other cross-functional teams to execute product portfolios and change controls associated with manufacturing and packaging master records, SOPs, protocols and any other relevant documents.
• Prepare documentation for regulatory purposes and coordinate with RA for drug dossier/variation filing and addressing deficiencies; provide relevant documents to RA in a timely manner for drug dossier/variation filing.
• Manage, review and challenge the project budget plan and track the expenses as needed

Qualifications:

• Bachelors or Master's degree in Pharmacy, Industrial Pharmacy.
• 10+ years of experience in manufacturing pharmaceuticals.
• Knowledge of PIC/s GMP and quality requirements related to pharmaceuticals including ICH, ASEAN Guideline.
• Must be proficient in computer skills & software applications such as Microsoft Office tools.
• Good command of English Language.