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Scientist, Analytical Sciences (R&D) (Solid State Chemistry)
Location:
Irvine, CA
Description:
We have an open position for a Scientist, Analytical Sciences (Solid State Chemistry) for our Research and Development department located in the Irvine, CA facility. RESPONSIBILITIES: Extensive hands-on laboratory experience and background knowledge in materials and chemistry related to active pharmaceutical ingredients and excipients. Characterization of pharmaceutical materials with analytical techniques such as PAS, XRD, etc. on particle size distribution and crystallography to assess solid state chemistry of the materials. Apply the obtained solid state chemistry test results for assessing material property and suitability for the function of the material in the product formulation. Knowledge and experience with generic pharmaceutical development and CMC practice for solid, semisolid, and liquid (oral) products. Good communication and leaderships skills as required for cross-functional collaborations. 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. Write method validation protocols/ reports and perform method validation/ verification for drug substances and drug products. Develop, validate, and troubleshoot stability-indicating methods for drug products. OOS and OOT investigations related to analytical testing results. Take lead to smoothly transfer the method to Quality Control chemists. Peer review notebooks, analytical methods, deviations, protocols, reports, SOPs and any other lab document. Provides training for new or existing department personnel. Other related duties as required er department management. QUALIFICATIONS: Bachelor’s degree in chemistry or Master’s Degree or PhD in chemistry with 7+ years experience in an analytical lab. 7 + years’ experience in an FDA regulated environment as well as familiarity with issues of compliance for State and Federal regulations. Problem-solving and trouble-shooting capability to routine works and some challenge projects. 7+ years' experience in test method validation in a pharmaceutical environment. Highly experienced in FDA, USP and ICH guidance. Solid working knowledge of MS Office programs. Organization and project management skills. Possess proficient use of the English language—both written and verbal. 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.
Company:
LGM Pharma Solutions
Posted:
March 22 on Oasis Applicant Tracking
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More About this Listing: Scientist, Analytical Sciences (R&D) (Solid State Chemistry)
Scientist, Analytical Sciences (R&D) (Solid State Chemistry) is a Science & Pharmaceutical Scientist Job at LGM Pharma Solutions located in Irvine CA. Find other listings like Scientist, Analytical Sciences (R&D) (Solid State Chemistry) by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Scientist, Analytical Sciences (R&D) (Solid State Chemistry) is a Science & Pharmaceutical Scientist Job at LGM Pharma Solutions located in Irvine CA. Find other listings like Scientist, Analytical Sciences (R&D) (Solid State Chemistry) by searching Oodle for Science & Pharmaceutical Scientist Jobs.