Manufacturing Associate I – Biopharma cGMP & Aseptic Ops

Replimune; Framingham, Northern (MA, KY); Hybrid; USD 79,000 - 103,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Year-end shutdown

Job summary

Replimune is seeking a Manufacturing Associate I/II at our Framingham, MA facility to execute cGMP manufacturing operations supporting our products. You will collaborate with multiple departments and assist with SOP generation, batch records, and deviations to ensure manufacturing readiness.

Responsibilities include aseptic gowning, equipment cleaning, inventory, preparing buffers, and operating single-use production equipment for viral production and filtration steps.

Qualifications

• Bachelor's degree and 1 to 3 years of related work experience in cGMP biopharma manufacturing preferred or
• Associate's degree or High School Diploma and 3 to 6 years of related work experience in cGMP biopharma manufacturing.
• Experience with single-use manufacturing technologies.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team player.

Responsibilities

• Author SOPs, batch records and deviations.
• Maintain the ability to aseptically gown or sterile gown as needed.
• Perform stocking and inventory of manufacturing supplies.
• Perform cleaning of process equipment and manufacturing suites.
• Follow procedures and complete production documentation accurately.
• Assist with setup and operation of single-use production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling.
• Become qualified to perform visual inspection of final product vials.
• Review completed manufacturing documentation.

Skills

Strong organizational skills

Attention to detail

Excellent written and oral skills

Team player

Education

Bachelor's degree in related field

1–3 years in cGMP biopharma manufacturing

Tools

Microsoft Word

Excel

Single-use manufacturing technologies

Job description

Replimune is seeking a Manufacturing Associate I/II at our Framingham, MA facility to execute cGMP manufacturing operations supporting our products. You will collaborate with multiple departments and assist with SOP generation, batch records, and deviations to ensure manufacturing readiness.

Responsibilities include aseptic gowning, equipment cleaning, inventory, preparing buffers, and operating single-use production equipment for viral production and filtration steps.