SCIENTIST I

LGM Pharma, LLC•Irvine, CA

About The Position

This role involves supporting analytical testing and screening for R&D raw materials and finished products under the guidance of senior staff. The Scientist I will also support method development, validation, and transfer for drug product development projects. Key responsibilities include conducting validation or verification of USP methods, writing and reviewing protocols, improving and modifying analytical methods, troubleshooting instrument and method issues, learning good documentation practices, and managing lab supplies and calibrations.

Requirements

Bachelor’s Degree (B.S.) or higher in Chemistry.
Adequate knowledge of chromatography and spectroscopy principles and operation.
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.

Nice To Haves

Experience in analytical instrument operation using HPLC, GC, FT-IR, and UV-Vis are preferred.

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.
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.