Manufacturing Associate

Manufacturing Associate

Provide support for development, manufacturing and production operations for regenerative medicine products in a clean room environment.

Main Job Tasks and Responsibilities:

  • Process blood-based regenerative medicine products
  • Support process development and production of biological products
  • Clean and maintain ISO Class 7 clean room
  • Perform preventative maintenance to equipment
  • Support quality control systems throughout the production and product development processes
  • Support qualifications of production equipment
  • Perform clean in place and line clearance procedures for routine manufacturing
  • Coordinate with R&D/QC for in-process testing and sampling
  • Support R&D activities with specific product testing needs
  • Recognize and report safety, maintenance, and operational variances
  • Communicate status of operations in a timely manner
  • Follow detailed operating procedures and batch records
  • Ensure compliance with Good Manufacturing Practices and safety requirements
  • Maintain files, records, and equipment
  • Record data, log activities and monitor processes
  • Achieve and maintain proficiency through training

Education and Experience:

  • Bachelor of Science or Arts degree from an accredited college / university with a major in biological, chemical, physical, or clinical laboratory science or engineering
  • Prefer experience in a hospital, biology, clinical or other regulatory laboratory or in hematology or phlebotomy

Key Competencies:

  • Attention to detail
  • Hands-on and highly motivated
  • Ability to follow written work instructions
  • Communication skills - verbal and written
  • Ability to work independently and in teams
  • Data collection, management, and analysis

Abilities Required:

  • Must be able to lift up to 50 pounds
  • Ability to stand/sit/walk 8+ hours a day