About This Opportunity

As a Manufacturing Technician III, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment.

Key Responsibilities

• May specialize in either purification or synthesis processes.
• As required, may cross train on basic or non-technical operations associated with other functions within the company.
• Maintain a clean and organized work environment in accordance with defined procedures.
• Assist Process Support Group in the execution of special projects and data collection.
• Demonstrate proficiency on the execution of key manufacturing processes which may include all or portions of the following: synthesis, cleavage and deprotection, chromatography, ultrafiltration , or freeze-drying
• Qualify lower levels on key manufacturing processes.
• May act as a lead for any given campaign.
• Review of basic cGMP documentation including solution and raw material reconciliation.
• Develop, review and revise SOPs and PIs to assure documentation reflects current operations.
• Qualify on basic investigational documentation including OOT, SHE, and CAPA's.
• Revise generic documentation to keep up with industry standards and customer expectations.
  
  
  

Required Skills/Abilities

• Minimum education requires high school diploma or equivalent with college level chemistry or equivalent work experience. A biotechnology certificate or college degree is preferred.
• Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids).
• Must have knowledge of relevant manufacturing processes which may include chemical synthesis, chromatography, ultrafiltration, freeze-drying, and aseptic technique.
• Experience in cGMP manufacturing environment.