SCIENTIST I

Primary Duties And Responsibilities

• Support analytical testing and screening for R&D raw materials and finished product with the guidance of Sr. staff in R&D lab.
• Support method development, validation, and transfer for drug product development project.
• Support lab activities of validation or verification of new or existing USP methods, write and review method validation/verification protocols under the guidance of Sr. staff of R&D lab.
• Conduct method improvements and modifications of new product analytical methods for drug substance and product under the guidance of Sr. staff of R&D lab.
• Learn to trouble-shoot problems of instruments or analytical methods for raw materials, finished product.
• Learn good documentation practice (GDP) for lab notebook taking and logbook filling.
• Facilitate lab supply management and purchasing and receiving.
• Facilitate lab balance and pH meter calibration.

Associated Duties And Responsibilities

• Operate HPLC, GC, ICP, UV, FTIR, dissolution, Malvern Particle Analysis, XRD, and other analytical instrumentation with training by Sr. staff of R&D lab.
• Analyze organic and inorganic compounds to determine chemical and physical properties with guidance of Sr. Stauff of R&D lab.
• Support method development, validation or verification, and method transfer related activities.
• Other related duties as assigned by lab Director.

Required Skills, Abilities, And Qualifications

• Bachelor's Degree (B.S.) or higher in Chemistry.
• Adequate knowledge of chromatography and spectroscopy principles and operation.
• Experience in analytical instrument operation using HPLC, GC, FT-IR, and UV-Vis are preferred.
• Work well in a team environment with good communication both verbal and written English language.
• Mastery in calculations with good lab records taking using lab notebooks, logbooks, and forms.
• Follow cGMP principles and FDA regulations for drug product development.
• Ability to read and interpret scientific articles and documents, such as method development publications, FDA regulations, safety rules, and procedure manuals.
• Ability to apply mathematical operations to tasks as determination of test reliability and validity, analysis of variance or RSD, and correlation coefficient with linear regression.
• Ability to define problems, collect data, establish facts, and propose solutions.
• Follow analytical procedures to conduct bench testing.