Manufacturing Associate II

Role Summary

Manufacturing Associate II responsible for end-to-end cell therapy manufacturing operations, ensuring adherence to cGMPs and GDPs to deliver high-quality products. Works in a cleanroom environment, performing manufacturing, documentation, and compliance activities to support patient need. Location: Rockville, Maryland and Redwood City, California.

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

• Bachelor’s degree in a relevant scientific field and 2+ years of industry experience in manufacturing (cell therapy, biologics, or aseptic manufacturing environment).

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

Education

• Bachelor’s degree in a relevant scientific field

Additional Requirements

• Flexibility to work weekends, holidays, or shift schedules as required