Job Description
Role: Analytical Chemist
Location: Utah, USA
Job Description
We are seeking a skilled Analytical Chemist to support laboratory testing activities within a regulated pharmaceutical environment. The ideal candidate will have hands-on experience with analytical techniques, GMP documentation, and pharmaceutical testing to support product development, release, and stability programs.
Key Responsibilities
- Perform routine and non-routine analytical testing of raw materials, in-process samples, and finished pharmaceutical products
- Execute testing using techniques such as HPLC, GC, UV-Vis, FTIR, Dissolution, Karl Fischer, and related methods
- Support method validation, verification, and transfer activities per ICH guidelines
- Conduct stability testing and maintain stability chambers as required
- Prepare, review, and maintain GMP-compliant documentation, including test results, protocols, and reports
- Investigate OOS, OOT, and deviations, and support CAPA activities
- Follow SOPs, cGMP, FDA, and data integrity requirements
- Maintain laboratory instruments, logs, and calibration records
- Support audits and inspections as needed
Required Qualifications
- Bachelor’s degree in Chemistry, Analytical Chemistry, or related scientific discipline
- 2–5+ years of experience in an analytical laboratory within the pharmaceutical or biotech industry
- Strong hands-on experience with HPLC (mandatory)
- Working knowledge of cGMP, GLP, USP, ICH, and FDA regulations
- Experience with laboratory documentation and electronic systems (LIMS preferred)
- Strong attention to detail and data integrity
Preferred / Nice-to-Have
- Experience with method development and validation
- Exposure to stability programs
- Experience with LC-MS or GC-MS
- Familiarity with regulatory inspections and audits
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