GMP Upstream Biotechnologist — Cell Culture Specialist

Northway Biotech; Waltham (MA); On-site; USD 100,000 - 170,000; Full time

Job summary

Northway Biotech in Waltham, MA, is seeking a USP GMP Biotechnologist to perform hands-on upstream manufacturing for mammalian or microbial cultures in a GMP CDMO-style environment.

You will execute seed train, bioreactor operations, harvest, media prep, aseptic techniques, and documentation while maintaining ALCOA+ data integrity and compliance. Prior GMP experience is essential; cell line development is a plus.

Qualifications

• BS in Biotechnology, Biology, Biochemistry, or related field.
• 6+ years of hands-on biopharmaceutical manufacturing experience, 2+ years in GMP environment.
• Experience executing GMP batch records and SOPs with contemporaneous documentation.

Responsibilities

• Execute upstream GMP manufacturing operations per batch records, SOPs, and schedules.
• Perform cell culture operations: thaw, shake flask expansion, seed train, inoculation, bioreactor operation, sampling, harvest.

Skills

GMP discipline

Aseptic execution

Data integrity

Clear communication

Teamwork

Safety focus

Education

BS in Biotechnology

Tools

LIMS

MES

EDMS

Job description

Northway Biotech in Waltham, MA, is seeking a USP GMP Biotechnologist to perform hands-on upstream manufacturing for mammalian or microbial cultures in a GMP CDMO-style environment.

You will execute seed train, bioreactor operations, harvest, media prep, aseptic techniques, and documentation while maintaining ALCOA+ data integrity and compliance. Prior GMP experience is essential; cell line development is a plus.