GMP QC Microbiology Associate Scientist

BioSpace; Pennington (NJ); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off

FSAs and HSAs

Life and AD&D insurance

Disability coverage

Commuter benefits

Well-being programs

Job summary

GenScript USA Inc/ProBio Inc. seeks a QC Microbiology professional to lead development and maintenance of a GMP QC-Microbiology Lab in a CDMO setting. You will participate in environmental monitoring, validation, and cGMP testing across a broad range of assays, contributing to process improvements and technology transfer.

The role emphasizes strong problem-solving, independent work, and teamwork within a fast-paced manufacturing environment supporting clinical material production.

Qualifications

• Master’s degree with 1 year of relevant work experience or Bachelor’s with 3 years of relevant work experience in Microbiology, Molecular Biology, Biochemistry, or related field.
• Experience in gene and cell therapy recombinant plasmid DNA products is a plus.
• Experience with Environmental monitoring and cleanroom activities.
• Experience in Mycoplasma testing or other cell culture and viral assays.
• Experience with GMP documentation (procedures, test methods, protocols, reports).
• Ability to problem solve and work independently and as part of a team.

Responsibilities

• Assist in the set-up, development and maintenance of a GMP QC-Microbiology Lab.
• Participate in EMPQ, cleanroom validation, and associated activities/documents.
• Follow cGMP in carrying out functions related to QC testing.
• Engage in Environmental Monitoring, Plate Reads, Water Testing, Gas Testing, Gram Staining, Growth Promotion, Bioburden, Gowning Qualifications and other QC-Microbiology activities.
• Test compounded sterile and non-sterile pharmaceuticals.
• Assist laboratory personnel to maintain quality and compliance with SOPs, cGMP protocols, and safety standards.
• Conduct mycoplasma testing and various virology and microbial assays.
• Demonstrate the ability to learn new skills and achieve proficiency.
• Support optimization initiatives to improve QC department.
• Perform other duties as assigned.

Skills

Microbiology

Molecular biology

Biochemistry

Environmental monitoring

Cell culture

Mycoplasma testing

GMP documentation

Problem solving

Education

Master’s degree in Microbiology

Bachelor’s degree in a related scientific field

Job description

GenScript USA Inc/ProBio Inc. seeks a QC Microbiology professional to lead development and maintenance of a GMP QC-Microbiology Lab in a CDMO setting. You will participate in environmental monitoring, validation, and cGMP testing across a broad range of assays, contributing to process improvements and technology transfer.

The role emphasizes strong problem-solving, independent work, and teamwork within a fast-paced manufacturing environment supporting clinical material production.