QC Microbiology Scientist I – GMP Lab

ProBio; Pennington (NJ); Vor Ort; USD 70.000 - 83.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off including vacation and S

Flexible spending accounts

Life and AD&D insurance

Disability coverage

Commuter benefits

Well-being programs

Peer recognition

Zusammenfassung

ProBio, a GenScript subsidiary, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. The role reports to the Manager of Microbiology and supports GMP manufacturing of clinical trial materials, contributing to technology transfer and process development.

The position focuses on environmental monitoring, QC testing, and method development, with exposure to EMPQ, cleanroom validation, and related cGMP activities, while

Qualifikationen

• Bachelor's degree in Microbiology, Biology, Biochemistry or related field with 2-5 years of relevant work experience.
• Familiar with Good Documentation Practices, Data Integrity, ALCOA+.
• Experience following Standard Operating Procedures or protocols.
• Ability to problem solve, and work independently and as part of a team.
• Strong interpersonal, verbal, and written communication skills.

Aufgaben

• Environmental Monitoring of cleanrooms, Water Testing, and Gas Testing.
• Support QC-Microbiology procedures: development, update of governing procedures and methods.
• Support QC-Microbiology product testing including routine and verification testing.
• Support QC-Microbiology media fills: monitoring and testing.
• Microorganism analysis including plate reads, Gram staining, Bioburden, Endotoxin, mycoplasma, and related QC activities.
• Participate in EMPQ, cleanroom validation, and related activities/documents.
• Maintain compliance with cGMP in QC testing.
• Assist optimization initiatives for lab inventory, workflow, and preparation.
• Perform other duties as needed.

Kenntnisse

Environmental monitoring

Good Documentation Practices

Data Integrity

ALCOA+

Problem solving

Independent work

Team collaboration

Verbal and written communication

Ausbildung

Bachelor's degree in Microbiology/Biology/Biochemistry or related field

Tools

Microsoft Office

Jobbeschreibung

ProBio, a GenScript subsidiary, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. The role reports to the Manager of Microbiology and supports GMP manufacturing of clinical trial materials, contributing to technology transfer and process development.

The position focuses on environmental monitoring, QC testing, and method development, with exposure to EMPQ, cleanroom validation, and related cGMP activities, while