Scientist, Analytical Sciences (R&D) (Solid State Chemistry)
LGM PHARMA SOLUTIONS LLC
- Irvine, CA
- Permanent
- Full-time
- 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.
- 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.