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  • Vista, CA

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Chemist II

Apex Life Sciences • Vista, CA

Posted 7 days ago

Job Snapshot

Full-Time
Degree - 4 Year Degree
Other Great Industries
Science
0

Applicant

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Job Description

Our client, a leading custom products manufacturer, is seeking a Chemist II to join their team.

SUMMARY:

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

REQUIRED:

  • 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.

PREFERRED:

  • Experience with Peptides
  • General lab instrument ( MS UV Spectrometry) knowledge and operation experience
  • Knowledge of cGMP and FDA regulations a plus

Send resumes to [Click Here to Email Your Resumé]

EEO Employer

Job ID: 792427
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