Process Development Associate - Thousand Oaks, CA

Overview

Process Development Associate – Thousand Oaks, CA. Posting by Vet Jobs in collaboration with Amgen. This on-site role focuses on analytical development activities in support of product release, stability, characterization, investigations, and regulatory submissions.

• Technical support of incoming method transfer/qualification, method optimization, troubleshooting method-related issues, and investigations in an early phase GMP environment.
• Implementing and executing LC/CE methods as part of product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions.
• Generating, analyzing, and critically evaluating analytical data to support product release and stability, process characterization, investigations, and regulatory submissions.
• May participate or contribute to analytical development teams by providing analytical updates, documentation, and data interpretation.
• Experimental design and data interpretation, leveraging in-house visualization and analytics tools.
• Communicating findings through oral presentations and written documentation (technical reports and GMP documents to support regulatory filings).
• May telecommute (flexibility depending on project needs).

• Minimum
  
  Education Required:
  
  High School/GED.
• Required:
  
  Bachelor’s degree (or foreign equivalent) in Biology, Biochemistry or related field, or equivalent university-level coursework/research/internship.
• Technical knowledge of proteins and peptides.
• Liquid Chromatography principles, including stationary/mobile phases, partitioning, and separation concepts.
• Experience handling chemicals and laboratory apparatus; laboratory safety and PPE usage.
• Ability to prepare and handle samples and chemical media; record experimental conditions, results, and observations in a lab notebook.
• Experience in setting up instruments and apparatus, monitoring reactions and data points; use of a fume hood for solvent/media preparation.
• Proficiency with Microsoft Excel, Word, and PowerPoint.

Additional role details:

• Job type:
  Full Time. Salary range in the U.S.: $79,971.00 – 89,221.00 per year.
• Location:
  
  Thousand Oaks, California.
• Employer:
  
  Amgen (affiliate sponsor).
• Employment type:
  
  Full-time;
  Seniority level:
  Entry level.