Key Responsibility
Proactively and effectively lead R&D teams, formulators and R&D analysts, through the effective planning and execution of drug development process 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.
Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
Create and review product milestones and SOPs, as well as relevant documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
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.
Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required
Manage, review and challenge the project budget plan and track the expenses as needed
Evaluate patents and develop non-infringement strategies
Interaction with API manufacturers, CROs, CMOs and outsourcing product developers/ laboratories as needed.
Support other activities relevant to quality issues
Qualification
Doctor's or Master's degree in Pharmacy, Industrial Pharmacy.
10+ years of experience in manufacturing pharmaceuticals.
5+ years of experience as R&D Manager position.
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.
Must be able to work under minimal supervision and able to work independently and in a team environment.
Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
Good communication skills, leadership skills and strategic thinking skills.
Good command of English Language.
