Manufacturing Associate

Title: Sr. Manufacturing Associate & Manufacturing Specialist

Location: Boston, MA (Seaport – Onsite)

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

Documentation & Floor SME Support

• Serve as the floor SME for manufacturing activities
• Author and review batch records and procedures
• Support same-day documentation activities
• Drive right-first-time execution
• 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
• Prior document writing 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
• Boston, MA (Seaport – Onsite)
• Tuesday–Saturday, 9:00 PM–7:30 AM
• 40 hours/week
• 6+ Month Contract with possibility of extension or conversion
• Training on 1st shift