SENIOR SCIENTIST (R&D)

We have an open position for a Senior Scientist in our Reseach and Development Department located in the Irvine, CA facility.

PRIMARY RESPONSIBILITY:

• Leading analytical development projects and responding to requests from internal and external customers related to CMC filings of ANDAs and NDAs.
• Lead and train junior Scientists in method development, validation or verification, and transfer.
• 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 in an analytical lab in addition to perform screening, release, and stability tests using these instruments.
• Fluent on application of MS Office software and chromatography data collection and management software such as Empower, ChemStation, etc.
• Support analytical methods and method development for pharmaceuticals (solids, semisolids, and liquid dosages) and confirm our products identity, potency, purity, and stability.
• Conduct method improvements and modifications on commercial analytical methods for pharmaceuticals.
• Conduct method development and USP method feasibility studies for assay, trace elements, particles size analysis, crystallography, and associated characteristics for pharmaceuticals.
• 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.
• Work with Lab Management 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 methods to QC chemists.
• Other lab related duties assigned by lab management.

QUALIFICATIONS:

• 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.
• 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 for pharmaceuticals.
• Must be a self-starter, work under limited supervision, and capable to take initiative in prioritization and implementation of work.
• 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.
• Must possess a command of the written English language to enable clear and accurate documentation of results.
• Proficient in advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations and able to apply mathematical operations to such tasks as determination of test reliability and validity, analysis of variance, correlation of techniques, sampling theory, and factor analysis.
• Strong team player; able to build rapport and work with other departments.
• Able to communicate professionally and concisely at all levels of the organization

Job Type: Experience

Schedule: Full-Time

Benefits: Medical, Dental, Vision, Matching company 401K, Vacation and Sick 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.