Analytical Chemist :
Under the direction of analytical services management, performs chemical testing following developmental protocols or approved methods, and participates in instrument validation. Conducts experiments using wet chemistry and appropriate laboratory instruments, collecting and interpreting analytical data and issuing reports in accordance with laboratory SOPs.
Essential Duties and Responsibilities:
Performs analytical methods on drug substances, drug product, and residual testing, using guidelines from USP and ICH. Assists in the development of protocols under which the methods transfer, optimization development, and validation are conducted. Writes test methods into company SOPs; reviews, writes, or assists in writing SOPs for analytical development. Performs USP Compendia testing and other Compendia testing as required. Consults with scientific professionals and scientific literature for problem solving assistance. Provides analytical testing support for manufacturing. Documents laboratory activity and files all data using appropriate log books, records, files, and equipment calibration logs. Operates laboratory equipment such as balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures, and in accordance with laboratory SOPs. Performs routine sample processing and dosage form analysis using HPLC, GC, UV-Vis, and other analytical instrumentation. Collates test results and prepares certificates of analysis and stability reports. Conducts peer review of other analytical chemists and scientists work. Observes safety rules and assists in keeping the laboratory a safe environment.
Technical Skills - Ability to operate analytical balance, HPLC, GC, UV/VIS Spectrophotometer, pH meter, FTIR, Karl Fischer Titrator, Automatic Titrator, Polarimeter, Specific Gravity Meter, and Melting Point Apparatus, and other modern analytical equipment.
Bachelor s degree in Chemistry or related scientific field with at least 2 years of analytical chemical experience. Pharmaceutical laboratory experience preferred. Equivalent combination of education and experience or training is acceptable.
To perform this job successfully, an individual should have computer skills with knowledge of Word, Excel, Access, Outlook, and ability to use internet tools. Empower Chromatography software experience is valuable.