Basic Functions:
Leads a project for assay design and developments, co-ordinate stability studies and marketing supports (trouble shooting 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, keep accurate records of work undertaken
- Supervise and support other team members in planning and execute experiments
- Follow standard operating procedures and safety guidelines and maintain a clean and orderly environment
- Engage in continuous learning and skill development
- Maintains 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, complaint and problem solving
- Assist new product clinical trials and new product transfer and provide necessary supports 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, suggests improvements, and initiates trouble-shooting.
- 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 experiences
