Sr. R&D Chemist

Irvine, CA

RESPONSIBILITIES:

  • Understand and run HPLC, GC, ICP, UV, FTIR, Dissolution tester and other analytical instrumentation in an analytical lab set up.
  • Work on MS Word, Excel, and any one of the chromatography data collection and management software such as Empower, ChemStation.
  • Validate/verify new and existing USP methods, and establish a documentation system for drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs 
  • Support analytical methods and method development for pharmaceuticals (solids, semisolids, and liquid dosages) and to enhance strength and purity confirmation of our products.
  • Conduct method improvements and modifications on commercial analytical methods for pharmaceuticals.
  • Conduct method development and USP method feasibility studies for assay, trace elements, and associated characteristics for pharmaceuticals.
  • Trouble-shoot problems associated with analytical methods for pharmaceuticals including raw materials, finished product method development, quantitative and qualitative analysis, and improvement of analytical methodologies
  • Work with Lab Manager to develop and build a system for pharmaceuticals analytical methods by establishing documentation protocols, including drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs
  • Analyze organic and inorganic compounds to determine chemical and physical properties.
  • Coordinate with our Quality Control department to smoothly transfer validated method to QC chemists.

QUALIFICATIONS: 

 

  • B.S. with 7+ years/ MS with 2+/ Ph.D. with related experience and/or training; or equivalent combination of education and experience in pharmaceuticals, medical devices or chemical industry.
  • Working knowledge of MS Word, Excell, and any one of the chromatography data collection and management software such as Empower, ChemStation etc.
  • Understand and apply cGMP principles and FDA regulations for pharmaceuticals.
  • Must be a self-starter, work under limited supervision, and capable to take initiative in prioritization and implementation of work.
  • Able to read and interpret scientific articles and documents, such as method development publications, FDA regulations, safety rules, and procedure manuals. 
  • Mastery in calculations and the recording of results of testing in lab books and laboratory reports according to SOPs and cGMP principles.
  • Must possess a command of the written English language to enable clear and accurate documentation of results.
  • Strong team player; able to build rapport and work with other departments
  • Able to communicate professionally and concisely at all levels of the organization
  • Proficient in advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations and able to apply mathematical operations to such tasks as determination of test reliability and validity, analysis of variance, correlation of techniques, sampling theory, and factor analysis.

  • Strong team player; able to build rapport and work with other departments Able to communicate professionally and concisely at all levels of the organization