Job Details

Join to apply for the Chemist II role at Pyramid Pharma Services.

Base pay range

$70,000.00/yr - $85,000.00/yr

Direct message the job poster from Pyramid Pharma Services

Under limited supervision, our Chemist II is responsible for performing routine analytical testing, method validation/transfer activities, preparing technical documentation, and maintaining laboratory equipment in the quality control analytical laboratory.

RESPONSIBILITIES

• Perform routine laboratory testing (i.e., HPLC, 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.


• Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed.


• With guidance, author and execute protocols for method transfer, qualification, and validation.


• Create data summaries and author technical reports.


• Develop and revise SOPs, as needed.


• Train and guide junior chemists.


• Perform QC peer-review of laboratory raw data for basic tests.


• Calibrate, maintain, and troubleshoot various basic analytical instruments, such as osmometers, pH/conductivity meters, balances, plate readers, etc.


• Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc., with guidance.


• 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

• Bachelors or advanced degree in analytical chemistry, biochemistry, or a related field


• 4+ years (with Bachelors) or 2+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products.


• Hands-on experience with HPLC, UV-Vis, and other common analytical equipment and techniques.


• Experience executing method validations and method transfers.


• Proficiency with Microsoft Office and laboratory software for data collection and analysis. Experience with Chromeleon CDS is preferred.


• Knowledge of ICH, USP, Ph. Eur., and other regulatory and quality guidelines preferred.


• Effective communication skills, both written and verbal, for interaction with staff and vendors.