Bachem

Bachem Torrance, CA, USA
Aug 04, 2020
Full time
Your Responsibilities The Chemist II (Chem. II) function is to work in a cGMP-regulated environment manufacturing active pharmaceutical products (APIs) as well as performing related activities at Bachem. Your Tasks 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 Production Records (MBPRs), Standard Operation Procedures (SOPs), Standard Test Procedures (STMs) and other procedures...
Bachem Vista, CA, USA
Aug 04, 2020
Full time
Your Responsibilities The QC Scientist II performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities. Your Tasks Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc. Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor Implement and maintain GMP procedures such as following SOP's, Standard Testing Procedures (STP's), written procedure and maintaining proper documentation as necessary...
Bachem Vista, CA, USA
Aug 04, 2020
Full time
Your Responsibilities The Facilities Maintenance Engineer will be responsible for equipment maintenance, installation and troubleshooting of manufacturing equipment, facility equipment and electrical systems in current operation at the company sites. This individual will also be responsible for all related projects and services related to the equipment and their timely completion while adhering to standard practices. In addition, he/she will be responsible for routine facility, visual and physical inspections. Your Tasks Responsible for maintenance and operational procedure for critical systems Provide support in planning and execution of shutdowns of equipment Responsible for trouble shooting and providing corrective action directives Participate in calibration process and cycle designs; implement the necessary process change through engineering change control procedures Collaborate with the validation department regarding change control...
Bachem Torrance, CA, USA
Aug 03, 2020
Full time
Your Responsibilities The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP 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...
Bachem Vista, CA, USA
Aug 03, 2020
Full time
Your Responsibilities The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP 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...
Bachem Vista, CA, USA
Jul 31, 2020
Full time
Your Responsibilities The Quality Assurance Specialist II fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training. Your Tasks Review validation protocols, data and reports, as assigned Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls Perform annual product quality reviews and system reviews as assigned Review raw material records Provide support to customer and regulatory audits. Conduct internal audits as assigned Implement improvements in quality systems and SOPs Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control Provide technical assistance on all production &...