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Senior Manufacturing Engineer
Manufacturing Technical Services, 23022-B-683-MFG
Confirmed live in the last 24 hours
Hayward, CA, USA
Experience Level
  • Bachelor's degree in relevant scientific or engineering discipline with 7+ years of experience in engineering, manufacturing and quality in biotech/pharma industry or Masters degree with 4+ years of relevant experience
  • Strong understanding of the Manufacturing Process
  • Strong skill in technical writing
  • Strong skill in CAPA development and management
  • Experience in cell culture or aseptic processing
  • Experience in cGMP cell therapy manufacturing
  • Strong knowledge of pharmaceutical manufacturing of biotechnology products and process development
  • Ability to share complex principles of knowledge to others
  • Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements and Manufacturing curriculum
  • Provide technical support for the manufacturing process, including process investigations, process changes, and technology transfer
  • Provide support to Process Sciences, QE, QC, MFG, QA, and Facilities through participation on cross functional teams
  • Lead activities on identifying, accessing, and executing appropriate CAPA for resolution of root cause related to Manufacturing process
  • Analysis of manufacturing process data
  • Investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
  • Conducts Risk Assessments/FMEA to support manufacturing activities including manufacturing process changes and technical transfers
  • Collaborate With stakeholders to write and/or revise SOPs, batch records, technical reports, and other operational related documents as support is needed
  • Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Support regulatory submissions and Quality Assurance with technical content and expertise
  • Other tasks and duties as assigned by Management

201-500 employees

Programmable cell therapy company
Company Overview
ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. ArsenalBio is creating products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
  • Medical, dental, & vision coverage
  • Virtual & telehealth options
  • Parental leave
  • Flexible work schedule
  • Flexible PTO
  • Mental health resources
Company Core Values
  • One Team
  • Transparency
  • Humility
  • Sustainability