- Conduct method improvement and modifications on commercial analytical methods for pharmaceuticals.
- Conduct method development and USP methods feasibility studies for essay, trace elements, and associated characteristics.
- 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.
- 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
- Understand and run HPLC, GC, ICP, UV, FTIR, Dissolution tester and other analytical instrumentation in an analytical lab set up.
- 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.
- Bachelor's degree in Chemist or MS with 2+/ Ph.
- 7+years' experience in a small molecule pharmaceutical environment or solid, semisolid, and liquid oral products.
- Experience with method development and method validation.
- 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 or ANDA filing documentation for pharmaceuticals.
- 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.
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Senior R&D Chemist - Irvine, United States - LGM PHARMA SOLUTIONS LLC
Description
We currently have an opening for a Senior R&D Chemist in our Research and Development team based in the Irvine, CA location.
Responsibilities:
Requirements / Qualifications:
Job Type:
Experience
Schedule:
Full-Time
At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer.
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.
