Analytical Chemist III at Pyramid Laboratories Inc

Costa Mesa, California, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Jul, 26

Salary

100000.0

Posted On

22 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

HPLC, LC/MS, UV-Vis, FTIR, CE, KF Titration, Method Development, Method Validation, Technical Writing, GMP, SOP Development, Data Analysis, Troubleshooting, Quality Control, Laboratory Equipment Maintenance, Instrument Calibration

Industry

Pharmaceutical Manufacturing

Description

POSITION SUMMARY: Under limited supervision, the Chemist III is responsible for performing routine analytical testing, supporting non-routine chemistry and development projects, method development/validation/transfer activities, preparing technical documentation, and maintaining laboratory equipment in the quality control analytical laboratory. RESPONSIBILITIES: * Perform routine laboratory testing (i.e., HPLC, LC/MS, UV-Vis, FTIR, CE, KF Titration, INSTRON, osmolality, pH, color/clarity, CCIT, particulate matter, wet chemistry) including finished product release, stability studies, and raw materials, following SOPs and GMP requirements. * Author and execute protocols for method transfer, qualification, and validation. * Support method development, non-routine projects, and analytical tech transfer/feasibility studies. * Perform technical evaluation of complex analytical data. Create data summaries and author technical reports. * Develop, author, and revise SOPs, as needed. * Train and guide junior chemists. * Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed. * Perform QC peer-review of laboratory raw data. * Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc. * Initiate problem-solving for technical issues commensurate with level of experience. * Assist with the implementation of new equipment, instruments, and software. * Support quality system activities, such as deviation investigations and laboratory OOS/OOT investigations. QUALIFICATIONS AND EXPERIENCE: * Bachelor’s or advanced degree in analytical chemistry, biochemistry, or a related field * 7+ years (with Bachelor’s) or 4+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products. * Strong knowledge of and hands-on experience with analytical techniques such as HPLC, GC, UV-Vis, mass spectrometry, and other common analytical equipment and techniques. * Experience with method development, technical writing, and executing method validations/ method transfers.

Responsibilities

The Chemist III performs routine analytical testing, method development, and validation activities within a cGMP quality control laboratory. They are also responsible for technical documentation, equipment maintenance, and providing guidance to junior staff.