Sr. Analytical Chemist

Irvine, CA

LGM Pharma is a leading contract development and manufacturing organization (CDMO) and provider of Active Pharmaceutical Ingredients (API). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, LGM is a premier end-to-end solutions provider to the global pharmaceutical industry.

We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We currently have offices in Colorado, California, Texas, Kentucky, Florida and Israel.

RESPONSIBILITIES:  

  • Perform analytical tests (wet chemistry, assay, impurity/degradant, dissolution and residual solvents in raw materials and finished products according to USP or in-house methods.
  • Perform method validation/verification for API and drug products.
  • Develop and troubleshoot test methods for finished products; write method validation protocols/reports.
  • Conduct some research.  Investigate failures in analytical testing results.
  • Address analytical issues in FDA deficiency letters.
  • Comply with cGMP regulations and follow all standard operating procedures.
  • Maintain and troubleshoot laboratory equipment and analytical instrumentation within level of experience.
  • Review peer’s notebooks; quality/technical review to ensure SOP/GMPs followed.
  • Train and guide lower level chemists with method development as needed.
  • Perform and/or assist with equipment calibrations and qualification
  • Other related duties as required.

QUALIFICATIONS:

  • Bachelors degree in chemistry or related discipline.
  • 5+ years experience in a chemistry laboratory, or equivalent combination of education and experience.
  • 5+ years experience with analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus.
  • 2+ years experience in GLP or GMP (preferred) environment.
  • Ability to follow standard operating procedures.
  • Strong communication skills, both written and verbal.
  • Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
  • Strong attention to detail.
  • Desire and ability to work in a positive team environment.