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Senior Manufacturing Associate
Confirmed live in the last 24 hours
Locations
Waltham, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Requirements
  • Must have experience with Cell Therapies
  • Must have experience working in a GMP environment
  • Must have technical knowledge to work as a liaison between MFG and Process Development
  • Self-motivated and detailed-oriented. Willing to be trained to new techniques
  • Ability to read and understand Standard Operating Procedures
  • Preferred experience with gene editing processes
  • Preferred experience with GMP document creation/revision
  • Preferred experience with Quality Management Systems
  • Strong organizational skills and attention to detail with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
  • Good communication skills and the ability to work independently, and as part of a team
  • Preferred experience with Excel and Microsoft Office applications
  • Bachelor's degree with 2-4 years of relevant experience
  • High School diploma and 4+ or more years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3+ year of GMP Manufacturing experience will be considered
  • Ability to pass sterile gowning qualification required
  • Previous cleanroom or cGMP experience is highly desirable
  • Fill/finish or aseptic technique training strongly preferred
  • Must be willing and able to travel between Cambridge and Waltham locations
Responsibilities
  • Lead/Train a clinical MFG team in a clean room environment while fully gowned following GMP guidelines and using aseptic technique
  • Generate, revise, review and approve SOPs, batch records and other quality documents to support internal manufacturing projects and ensure all documents are maintained to accurately reflect the most current process
  • Lead troubleshooting of process and equipment problems with manufacturing, process development and quality teams
  • Operate instrumentation required for cell manufacturing and gene editing
  • Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed
  • Work in a Biological Safety Cabinet for open processing operations
  • Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation
  • Maintain orderly lab space
  • Maintain sufficient inventory of supplies and reagents for performance of duties. Clean and maintain laboratory equipment in good working order
  • Prepare solutions and culture media as appropriate
  • Work in compliance with all appropriate laboratory regulatory and safety requirements
Editas Medicine

51-200 employees