Production Chemist I BSD API 3

Company: Bachem
Location: Vista
Posted on: January 12, 2021

Job Description:

The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP (2nd shift 2pm - 10:30pm) material and perform related activities at Bachem. Your Tasks: Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails Perform purification process by chromatography, crystallization and other techniques, and in-process test method 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 Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, Lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture Develop processes for purification of chemicals other than peptides Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help 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 Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist QA/QC for monitoring raw material inventories Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records 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 Your Profile: BS degree in Chemistry or related field 1-3 years' work experience Experience with HPLC and chromatography May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides General lab instrument (MS UV Spectrometry) knowledge and operation experience Knowledge of cGMP and FDA regulations We Offer: You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego

Keywords: Bachem, Vista , Production Chemist I BSD API 3, Other , Vista, California