Manufacturing Associate II

Role Summary

As a Manufacturing Associate II, your mission is to deliver to patients every time!

Responsibilities

• Key Responsibilities
• Accurately follow manufacturing batch records (MBRs) and standard operating procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs)
• Execute end-to-end cell therapy manufacturing operations including:
• Operation of manufacturing equipment for batch production
• Media preparation, reagent handling, buffer preparation
• Aseptic processing in controlled cleanroom environments
• Document all activities in accordance with Good Documentation Practices (GDPs)
• Support deviation investigations, CAPA execution, and change control activities
• Complete all training activities required to maintain quality compliance.
• Maintain strict compliance with regulatory and internal quality standards
• Perform routine maintenance activities required for a GMP environment

Qualifications

• Required: Bachelor‚Äôs degree in relevant scientific field and 2+ years of industry experience in manufacturing (cell therapy, biologics, or aseptic manufacturing environment)
• Required: Familiarity with mammalian cell culture and aseptic techniques
• Required: Ability to operate within a clean room environment for long duration
• Required: Understanding of GMP principles and cleanroom operations
• Required: Excellent organizational and prioritization skills
• Required: Exceptional collaboration, communication, and interpersonal skills
• Required: Flexibility to work weekends, holidays, or shift schedules as required

Skills

• Familiarity with mammalian cell culture and aseptic techniques
• Ability to operate within a clean room environment for long duration
• Understanding of GMP principles and cleanroom operations
• Excellent organizational and prioritization skills
• Exceptional collaboration, communication, and interpersonal skills
• Flexibility to work weekends, holidays, or shift schedules as required