Scientist, Analytical Sciences (R&D) (Solid State Chemistry)

LGM PHARMA SOLUTIONS LLC

  • Irvine, CA
  • Permanent
  • Full-time
  • 1 month ago
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: ExperienceSchedule: Full-TimeAt 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.

LGM PHARMA SOLUTIONS LLC