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Senior Manufacturing Associate

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Simi Valley, United States Astrix Full time

Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Sr. Manufacturing Associate

Job Responsibilities:

  • Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes
  • Lead sophisticated projects or parts of projects using project management skills.
  • Resolve quick issues and execute function tests to troubleshoot and optimize process
  • Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
  • Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
  • Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
  • Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
  • Demonstrate strategic problem-solving skills and champion continual improvement.
  • Ability to be on-site (flexible worker)
  • Support New Product introduction and projects through Single Use Systems (SUS) mapping
  • Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
  • Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
  • Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects

Qualifications:

  • Degree in Engineering or Life Sciences
  • Previous GMP experience
  • Technical knowledge of drug substance processing
  • Preferred proficiency in Smartsheet, Excel, Trackwise, visio, pi, SAP, Spotfire.