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- Vista, CA
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Apex Life Sciences • Vista, CA
Posted 7 days ago
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Our client, a leading custom products manufacturer, is seeking a Chemist II to join their team.
This function is to develop peptide manufacture process, manufacture GMP material and perform related activities.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
- 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, lyophilizers, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture
- Follow SOPs and approved directions to clean equipment, glassware used in GMP processes and maintain cleaning logs for each equipment
- 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
- Dispose chemical waste generated in the manufacture
- 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
- Develop processes for purification of chemicals other than peptides
- Assist QA/QC for monitoring raw material inventories
- Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents
- BS degree in Chemistry or related disciplines
- 3+ years’ work experience
- Experience with HPLC and chromatography
- May work with hazardous materials and chemicals
- Exhibit detail oriented documentation skills
- Ability to follow directions
- Ability to effectively organize, multitasks, and works in a fast-paced, deadline driven work environment.
- Excellent written and oral communications skills
- Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.
- Ability to work independently and manage one's time
- Basic computer knowledge, including Microsoft word and excel (used daily)
- Communicate effectively and ability to function well in a team environment
- Environment requires that gowning in the form of bunny suits, gloves, hair net, no makeup or jewelry can be worn when working in the clean room environment.
- Experience with Peptides
- General lab instrument ( MS UV Spectrometry) knowledge and operation experience
- Knowledge of cGMP and FDA regulations a plus
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