Senior cGMP Manufacturing Associate - 2nd Shift

Replimune; Framingham (MA); On-site; USD 95,000 - 122,500; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Paid holidays including year-end

Year-end shutdown

Job summary

Replimune is seeking a Senior Manufacturing Associate to execute cGMP manufacturing operations at the Framingham, MA facility, supporting tech transfer and startup activities and helping generate SOPs and related documentation.

This is a 2nd shift, 4-day Mon–Thu, 10-hour schedule with on-site expectation; the role requires collaboration across disciplines, rigorous adherence to quality systems, and the ability to operate single-use production equipment.

Qualifications

• Minimum of 3 years working in cGMP environment.
• Experience in two or more functional areas (Cell Culture, Purification, or aseptic filling).
• Experience with single-use manufacturing technologies.

Responsibilities

• Author SOPs, batch records, deviations and change controls.
• Maintain ability to aseptically gown and sterile gown as needed.
• Stocking and inventory of manufacturing supplies.
• Clean of process equipment and manufacturing suites.
• Ensure training requirements are up to date in operations.
• Assemble, clean and autoclave process components and equipment.
• Prepare buffers and solutions following approved processes.
• Perform aseptic operations within biosafety cabinets and clean rooms.
• Setup and operate single-use production equipment for viral production and filtration steps.
• Qualified to perform visual inspection of final product vials.
• Follow procedures and document production steps accurately.
• Review completed manufacturing documentation.
• Act as SME or system owner for specific equipment.

Skills

Cross-functional collaboration

Attention to detail

Clear written & verbal communication

Team player

Education

Bachelor’s degree in related field

Associate’s or high school with 5–8 years experience

Tools

Single-use manufacturing technologies

Microsoft Word & Excel

Job description

Replimune is seeking a Senior Manufacturing Associate to execute cGMP manufacturing operations at the Framingham, MA facility, supporting tech transfer and startup activities and helping generate SOPs and related documentation.

This is a 2nd shift, 4-day Mon–Thu, 10-hour schedule with on-site expectation; the role requires collaboration across disciplines, rigorous adherence to quality systems, and the ability to operate single-use production equipment.