หน้าที่ความรับผิดชอบ

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