Chemist

A brief overview  The role of the Chemist is to manufacture active pharmaceutical ingredients (APIs) and perform related activities within a cGMP regulated environment. What you will do Install, operate and maintain equipment for manufacturing and in-process testing (HPLC/UPLC, lyophilizers, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems, et al.) 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 via 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 deviations and produce reports; Initiate document change request; Assist quality control and assurance unit to maintain equipment calibration program  Maintain/organize work areas (hood, bench, floor, wall, etc.) and other designated areas within 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  Qualifications  Bachelor’s degree in chemistry or related field (in lieu of degree, will consider 10+ years relevant experience) Experience in using general lab instrumentation (e.g. HPLC, UV Spectrometry) Experience in GMP manufacturing as well as basic knowledge of cGMP and FDA regulations (preferred) Experience in the manufacture of peptides and oligonucleotides (preferred) Capable of following GMP guidelines and housekeeping rules Excellent written and oral communication skills Communicate effectively and ability to function well in a team environment Ability to communicate in a proactive and solution-focused manner, including keeping direct supervisor aware of potential issues. Ability to accommodate four 10-hour shift schedules each week with start times as early as 5:00am or as late as 3:00pm (including either a Saturday or Sunday) Ability to work independently and manage…