Manufacturing Associate (3rd Shift)

JMD Technologies Inc.; Boston (MA); On-site; USD 55,000 - 76,000; Full time

Job summary

JMD Technologies Inc. in Boston is seeking a Manufacturing Associate for the 3rd shift to support clinical cell therapy manufacturing in a cGMP environment.

The role focuses on hands-on aseptic processing, batch record and procedure authoring/review, right-first-time execution, and execution of technical projects. The incumbent will serve as the floor SME for manufacturing activities, participate in technology transfer, and collaborate with Development and Quality to advance SOPs and

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.

Job description

Title: Manufacturing Associate (3rd Shift)

Employment Type: Contract

Status: Accepting Candidates

About the Role

We are seeking a Manufacturing Specialist to support clinical cell therapy manufacturing in a cGMP environment. This role serves as a floor SME and focuses on hands-on aseptic processing, batch record and procedure authoring/review, right-first-time execution, technical projects, technology transfer, and accelerated onboarding.

Key Responsibilities

Cell Therapy Manufacturing

• 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

Technical Projects & Operations

• 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

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

Preferred Qualifications

• Leadership experience is a strong plus
• Experience serving as a manufacturing floor SME
• Experience supporting technical projects and technology transfer
• Experience driving right-first-time execution
• Ability to complete an accelerated onboarding

Compensation

• $40-$55/hr
• Tuesday-Saturday, 9:00 PM-7:30 AM
• 40 hours/week
• 6+ Month Contract with possibility of extension or conversion