SCIENTIST III / SENIOR

We are in need of a R&D Scientist III/Senior to join the R&D Team located in Irvine, Ca.

PRIMARY DUTIES AND 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.
• Analyze organic and inorganic compounds to determine chemical and physical properties.
• Develop stability-indicating test methods for finished products.
• Design method validation protocols and write reports, perform method validation or verification for API and drug products.
• Conduct research and troubleshoot for instruments, methods, and tests with supervision.
• Coordinate with Quality Control department to smoothly transfer the method to QC chemists.
• Responsible for calculations and recording results of all tests in lab books and laboratory reports with good documentation practice for cGMP compliance.
• Perform peer review on lab notebooks, logbooks, and lab records.
• Train new chemists.
• Other related duties assigned by lab Director.

REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:

• Bachelor’s degree (BS) or higher in Chemistry or equivalent combination of education and experience
• 5 years of related experience and/or training in a Pharmaceutical company 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.
• Experience in supporting CMC documents for ANDA filing is preferred.
• Work well in a team environment with good communication skillset in both verbal and written English language for clear and accurate documentation of results and communication 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.
• Lead and train junior Scientist taking initiative in prioritization and implementation of work.
• Ability to interpret scientific and regulatory articles and documents, such as method development publications, FDA regulations, USP monographs and general chapter tests, safety rules, and procedures.
• Experienced in applying mathematical operations for 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 accurately interpret and implement variety of technical instructions and procedures.
• Experience with FDA audit for cGMP compliance is desirable.

• Experience on wet chemistry and HPLC/GC
• Proficiency with MS Office programs (Word, Excel, Power point).
• Ability to foster good teamwork and leadership skills.

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.