Basic Functions:Leads a project for assay design and developments, coordinates stability studies and marketing supports (troubleshooting assays).Duties:Plan and conduct experiments according to project plans and keep timelines.Design and conduct investigations and experiments, record and analyze or interpret the results in support of project development objectives, and keep accurate records of work undertaken.Supervise and support other team members in planning and executing experiments.Follow standard operating procedures and safety guidelines and maintain a clean and orderly environment.Engage in continuous learning and skill development.Maintain and implement ISO 13485 / FDA QSR 21 CFR: PART 820 and other relevant international standards and regulations.Communicate and collaborate with other professionals in the lab.Ensure necessary and effective support for operations and marketing on technical issues, customer special requirements, complaints, and problem-solving.Assist new product clinical trials and new product transfer and provide necessary support such as developing procedures and standards for product launching.Conduct initial review for study protocols & reports and other documents to support R&D projects prior to external review.Identify process problems, suggest improvements, and initiate troubleshooting.Provide adequate and appropriate training for subordinates.Assist with lab planning and equipment calibration and maintenance.Other projects as assigned by department manager.Requirements:– Ability to: Lead a project team in carrying out the task.– Knowledge of: Immunodiagnostics, microbiology.– Education: PhD; MSc/MEng; Good Honors degree; or equivalent.– Experience: At least 2-6 years of relevant work experience.#J-18808-Ljbffr