SCIENTIST II

LGM Pharma, LLC•Irvine, CA

6d•$30 - $36

About The Position

The Scientist II will support analytical method development, validation, and transfer for drug product development. This includes formulation development, stability tests, and release tests. The role involves validating/verifying new or existing USP methods, writing and reviewing method validation/verification protocols, reports, analytical methods, and SOPs. The scientist will also conduct method improvements and modifications on commercial or new product analytical methods for drug substance and product for continued improvements, and troubleshoot instrument or analytical method problems for raw materials and finished products. Good documentation practice is essential for lab notebooks, logbooks, validation and verification reports, stability studies, lot release testing, and protocol-driven R&D studies. The position also includes conducting method development and USP method feasibility studies for assay, trace minerals, and associated characteristics for drug products. Associated duties include operating various analytical instruments such as HPLC, GC, ICP, UV, FTIR, dissolution, Malvern Particle Analysis, and XRD, and analyzing organic and inorganic compounds to determine their chemical and physical properties. The role also involves method development, validation or verification, and method transfer, and other related duties as assigned by the lab Director.

Requirements

Bachelor’s Degree (B.S.) or higher in Chemistry, with two or more years of related experience and/or training; or equivalent combination of education and experience.
Worked in a Pharmaceutical company (4 years or more) on small molecules with good documentation practice/cGMP.
Developed and validated analytical methods using HPLC, or GC, for assay, impurity, residual solvents, and dissolution.
Hands on experience using Empower software.
Work well in a team environment with good communication both verbal and written English language for clear and accurate documentation of results and communicate for project update.
Mastery in calculations with good lab records for lab notebooks, logbooks, and laboratory reports according to good documentation practice for cGMP compliance.
Ability to understand cGMP principles and FDA regulations for drug product development.
A self-starter, working under limited supervision, and capable of taking initiative in prioritization and implementation of work.
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, correlation coefficient with linear regression, as well as difference (f1) and similarity factor (f2).
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

Nice To Haves

Experience in supporting CMC documents for ANDA filing is preferred.
Experience with FDA audit for cGMP compliance is desirable.

Responsibilities

Support analytical method development, validation, and transfer for drug product development including formulation development, stability tests, and release tests.
Validate/verify new or existing USP methods, write and review method validation/verification protocols, reports, analytical method, and SOPs.
Conduct method improvements and modifications on commercial or new product analytical methods for drug substance and product for continued improvements.
Trouble-shoot problems of instrument or analytical methods for raw materials, finished product.
Maintain good documentation practice for lab notebook, logbook, validation and verification report, stability studies, lot release testing, and protocol driven R&D studies.
Conduct method development and USP method feasibility studies for assay, trace minerals, and associated characteristics for drug products.
Operate HPLC, GC, ICP, UV, FTIR, dissolution, Malvern Particle Analysis, XRD, and other analytical instrumentation.
Analyze organic and inorganic compounds to determine chemical and physical properties.
Perform method development, validation or verification, and method transfer.
Perform other related duties as assigned by lab Director.