Chemist

The Chemist function is to work in a cGMP regulated environment manufacturing active pharmaceutical products (APIs) as well as performing related activities at Bachem. Install, operate and maintain equipment for manufacturing and in-process testing. The equipment includes but not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacture Perform solid phase and liquid phase synthesis, deprotect and cleave the API from the resin using chemical cocktails, containing HF, TFA, ammonium hydroxide or other chemicals Perform purification process by chromatography, crystallization and other techniques Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Follow and maintain GMP Documentation System. Investigate in deviations and write process deviation reports. Initiate document change request. Assist quality control and assurance unit to maintain equipment calibration program Routinely maintain/organize work areas (hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Write and improve Standard Operation Procedures (SOP), Standard Test Procedures (STM), Master Batch Records (MBPR) and other related GMP documents Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture Monitor compliance of maintenance and cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Takeover housekeeping ownership of production equipment and rooms