Scientist
$70,000–$75,000 year
On-siteMelrose Park, Illinois, United States
Job Summary
Conduct all aspects of Analytical Development, including method development, experimentation, and record keeping to ensure robust laboratory performance. Execute raw material release, stability, and formulation testing while performing validations or verification of methods for transfer to Quality Technologies or Quality Control. Manage stability programs by running testing protocols, generating finished product COAs, and providing updates to Regulatory Affairs and project teams. Plan and implement scientifically designed experimental programs for analytical method development and testing, accurately documenting procedures to meet corporate and GMP requirements. Review and approve validation protocols, reports, data packages, and SOPs. Requires BS in Chemistry with 3+ years of experience in chromatography (HPLC, GC) and pharmaceutical analytical operations under FDA and GMP regulations.
Required Qualifications
- BS degree in Chemistry or related degree
- 3+ years of related experience
- Skills in chromatography, such as HPLC, GC, TLC, IC and/or skills in handling wet chemistry and operating basic lab instruments, such as pH, Osmometer, Colorimeter, HIAC, particle size analyzers, FTIR, Karl Fischer methods 1a and 1c, UV/Vis, specific rotation, residue on ignition, manual titrations, loss on drying, etc.
- Skills in designing and executing experiments using different lab instruments and techniques
- Knowledge of statistical analysis/interpretation
- Knowledge of pharmaceutical dosage forms
- Knowledge of concepts in developing novel drug delivery systems
- Familiarity with concepts of pharmaceutical analytical operations including FDA and GMP regulations
- Strong verbal and written communication skills
- Strong problem-solving skills
- Strong interpersonal skills
- Ability to effectively speak, read, write, and understand English
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