Chemist Wavecrest Staffing Group LLC Vista, CA Job Details 1 hour ago Qualifications Computer literacy Full Job Description About the Company Our client is an innovation-driven, global manufacturer of specialty pharmaceutical ingredients with decades of experience supporting research, clinical development, and commercial programs for pharmaceutical and biotechnology companies worldwide. They are growing their US manufacturing team and are looking for Chemists at multiple levels. Role Overview The Chemist manufactures active pharmaceutical ingredients (APIs) and performs related activities within a cGMP regulated environment. What You Will Do Install, operate, and maintain manufacturing and in-process testing equipment (HPLC/UPLC, lyophilizers, balances, reactors, cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems, and more) Perform solid phase and liquid phase synthesis, then deprotect and cleave the API from the resin using chemical cocktails containing acids, bases, or other chemicals Perform purification via chromatography, crystallization, and other techniques Follow approved GMP manufacturing directions such as Master Batch Records, SOPs, and Standard Test Procedures to manufacture GMP materials, perform in-process testing, and package product Perform project planning and initiate raw material order requests; receive raw materials, coordinate with QA/QC and Material Management for release, and monitor inventory Follow and maintain the GMP documentation system; investigate deviations and write reports; initiate document change requests; assist QC and QA in maintaining the equipment calibration program Maintain and organize work areas (hood, bench, floor, walls, and other designated areas) within the manufacturing facility Write and improve SOPs, Standard Test Procedures, Master Batch Records, and other GMP documents Clean equipment per approved procedures, maintain cleaning logs, assist with calibration, and dispose of chemical waste generated in manufacturing Monitor compliance of equipment maintenance and cleaning procedures by periodically reviewing and signing off on logs Qualifications Bachelor's degree in chemistry or a related field (10+ years of relevant experience will be considered in lieu of a degree) Experience using general lab instrumentation (e.g., HPLC, UV spectrometry) Experience in GMP manufacturing and basic knowledge of cGMP and FDA regulations (preferred) Experience in the manufacture of peptides or oligonucleotides (preferred) Ability to follow GMP guidelines and housekeeping rules Excellent written and oral communication skills; able to work well in a team and keep the direct supervisor aware of potential issues Ability to work independently, manage time, and multitask in a fast-paced, deadline-driven environment Detail oriented with strong troubleshooting and problem-solving skills Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint Ability to work with hazardous materials and chemicals Ability to work four 10-hour shifts per week, including either a
Saturday or Sunday Schedules Available Shift A:
Sunday through Wednesday (alternating weeks Sunday through Tuesday), 3:00pm to 1:30am
Shift B:
Wednesday through Saturday (alternating weeks Thursday through Saturday), 3:00pm to 1:30am #INDBH