MP Biomedicals Asia Pacific

About MP Biomedicals Asia Pacific

Roles & Responsibilities Basic Functions: Responsible for research and development of Diagnostic/Life Science products for the Company. Responsible for formulating program plans, developing goals and objectives, directing the day-to-day program research, evaluating and interpreting program results. Provides Technical Support for worldwide registration of MP diagnostic products, including CE Mark, FDA & SFDA registration as well as WHO prequalification. Identifies, network with and initiates relationships with leading researchers and Institutes, to support R&D projects. Duties: Provides necessary direction/guidance to ensure adequate design of new products and process and their scale up and transfers to the Manufacturing. Ensures that development works result in new or improved products. Makes sure all development procedures of new products or improving existing products should follow International regulatory standards like ISO 13485 / FDA QSR 21 CFR: PART 820 standards. Establishes and administers procedures or protocols covering the research, design, development, alteration and improvement on new and existing programs. Advises and assists the staff in matters pertaining to basic research and developments. Recommends modifications and implements approved changes when necessary. Identifies the responsibilities and authorities of staff reporting to him/her and their training needs. Carries out advance basic research investigations. Ensures new products are well validated using regulatory standards for reproducibility, reliability and maintainability under expected storage and operational conditions prior to production Requirements: Ability to: Plan, conduct and evaluate a large, complex, multi-disciplined Basic Research Program, recruit and maintain an adequate staff, prepare acceptable reports and publications of program findings. Knowledge of: Research and Development program, planning, management and evaluation. Market research, competitive analysis, disease/product knowledge and strategic planning. Education: PhD in Biology/Microbiology/Biochemistry or Science related Experience: At least 5 years of relevant working experiences

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