Job Summary:

Laboratory position which involves development and validation of analytical methodology in support of the research projects involving testing of pharmaceutical components and/or drug products. Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.

Job Responsibilities

• Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
• General knowledge of cGMP and FDA requirements.
• Perform stability testing for GMP and R&D finished products
• Conduct analytical testing of API, excipients and components following compedial and validated methods
• Perform analytical method validation and method transfer with a minimum supervision.
• Follow company’s SOPs, STPS and comply with safety regulations.
• Maintain detailed record of experiments in the laboratory notebook.
• Timely communicate to supervisor(s) the obtained data and any issues aroused during testing
• Ability to analyze and interpret the analytical data under minimum supervision.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under the supervision.
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned

Job Requirements

• Education

  • Bachelor’s degree (B.S.) in chemistry or related field
  • Master’s degree (M.S.)

• Knowledge, Skills and Abilities

• General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, correlation techniques

• Analytical chemistry and common instrumentation

• General understanding of HPLC, GC, Drug Release, UV, IR, Titration.

• Using common computer software and analytical applications programs.

• Writing and interaction in English

• Experience

  • At least two (2) to five (5) years experience in pharmaceutical laboratory (B.S)
  • At least zero (0) to three (3) years experience (M.S.)