Senior Cell Therapy Manufacturing Specialist

JMD Technologies Inc.

Boston (MA)

On-site

USD 55,000 - 76,000

Full time

12 days ago

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Job summary

JMD Technologies Inc. in Boston seeks a Sr. Manufacturing Associate & Manufacturing Specialist to support clinical cell therapy manufacturing in a cGMP environment.

This role serves as a floor SME, focusing on hands-on aseptic processing, batch record and procedure authoring/review, right-first-time execution, and collaboration with Development and Quality teams. The role also supports technology transfer, documentation, and accelerated onboarding, with a 40-hour work week on a Tuesday–Saturday

Qualifications

  • 5–6 years of cGMP cell therapy manufacturing experience.
  • Hands-on aseptic technique/aseptic processing experience.
  • Experience authoring and reviewing batch records and procedures.
  • Strong cGMP manufacturing experience.

Responsibilities

  • Perform clinical product manufacturing for cell therapy according to cGMP standards
  • Assemble raw materials, follow SOPs, perform aseptic processing, complete batch records, and report deviations
  • Demonstrate and assist others with aseptic technique
  • Ensure cGMP compliance through consistent execution
  • Serve as the floor SME for manufacturing activities
  • Author and review batch records and procedures
  • Support same-day documentation activities
  • Support development of SOPs and other manufacturing documentation in collaboration with Development and Quality groups
  • Support technology transfer and final process development from Development to Manufacturing
  • Support technical projects and manufacturing initiatives
  • Ensure raw materials are identified and available in time for manufacturing activities
  • Transfer raw materials inside cleanroom suites using sanitizing reagents
  • Support coordination of resources within the Operations group
  • Work in a cleanroom and office setting
  • Occasionally move lab equipment and materials weighing up to 50 pounds
  • Work with compressed gases and LN2

Skills

cGMP cell therapy
Aseptic technique
Batch records
Documentation
Floor SME

Job description

JMD Technologies Inc. in Boston seeks a Sr. Manufacturing Associate & Manufacturing Specialist to support clinical cell therapy manufacturing in a cGMP environment.

This role serves as a floor SME, focusing on hands-on aseptic processing, batch record and procedure authoring/review, right-first-time execution, and collaboration with Development and Quality teams. The role also supports technology transfer, documentation, and accelerated onboarding, with a 40-hour work week on a Tuesday–Saturday

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