Analytical Method Specialist

3 weeks ago


Irvine, California, United States LGM Pharma, LLC Full time
Job Title: Analytical Method Specialist
Estimated Salary: $115,000 - $155,000 per year

LGM Pharma, LLC is seeking a highly skilled Analytical Method Specialist to join our Research and Development Department in Irvine, CA. This is an excellent opportunity for a talented professional to lead analytical development projects, respond to requests from internal and external customers related to CMC filings of ANDAs and NDAs, and train junior Scientists in method development, validation, or verification, and transfer. The successful candidate will design protocols for validation of USP category I, II, III, and IV methods, write validation or verification reports for CMC filing, arrange and facilitate PM and qualification of HPLC, GC, ICP, UV, FTIR, Dissolution tester, and other analytical instrumentation, and perform screening, release, and stability tests using these instruments.

The ideal candidate will have a B.S. with 8+ years, MS with 2+/ Ph.D. with related experience and/or training; or equivalent combination of education and experience in pharmaceuticals, medical devices, or chemical industry. You must have working knowledge of MS Word, Excell, and any one of the chromatography data collection and management software such as Empower, ChemStation, etc. You should understand and apply cGMP principles and FDA regulations for pharmaceuticals, be a self-starter, work under limited supervision, and capable to take initiative in prioritization and implementation of work. You must possess a command of the written English language to enable clear and accurate documentation of results. Strong team player skills, ability to build rapport and work with other departments, and proficient in advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations are essential.

We offer a comprehensive benefits package including Medical, Dental, Vision, Matching company 401K, Vacation and Sick Time. We are an equal opportunity employer and all suitably qualified candidates will receive consideration for employment based on objective work-related criteria without regard for age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity.

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