QC Microbiology Lead — In-Process & EM/UM Testing

NCBiotech; North Carolina; On-site; USD 81,000 - 105,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

Tuition reimbursement

401(k) with company matched

Paid vacation and holidays

Job summary

Biogen in RTP, North Carolina, is seeking a QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at the drug substance manufacturing facility. The role leads key operational aspects of the QC Microbiology laboratory and trains others in microbial testing.

You will review data, perform and troubleshoot assays, and contribute to method qualification and projects, with some overtime as required by business needs.

Qualifications

• Bachelor’s degree in microbiology, biology, or related field required.
• Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing.
• LIMS experience, including electronic notebooks.
• Knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring) and aseptic techniques.
• Experience with document control and editing technical documents.
• Intermediate statistics knowledge to analyze data and trends.
• Ability to follow procedures and complete technical tasks.
• Able to meet cleanroom and aseptic gowning requirements.
• Strong written and verbal communication skills; proficient in Word and Excel.

Responsibilities

• Review test data in LIMS and prepare quarterly EM/UM reports.
• Perform microbiology testing (bioburden, endotoxin, plate reading, ID).
• Conduct environmental monitoring in controlled manufacturing areas.
• Troubleshoot complex assays and participate in investigations.
• Comply with SOPs and controlled documents; maintain lab readiness.
• Overtime as required; maintain inventory and lab cleanliness.

Skills

LIMS experience

Bioburden testing

Endotoxin testing

Environmental monitoring

Aseptic techniques

Documentation control

Statistical data analysis

Gowning & cleanroom

Written & verbal communication

Laboratory organization

Education

Bachelor’s in Microbiology, Biology, or related field

Tools

LIMS

Veeva

Kneat

Microsoft Office

Job description

Biogen in RTP, North Carolina, is seeking a QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at the drug substance manufacturing facility. The role leads key operational aspects of the QC Microbiology laboratory and trains others in microbial testing.

You will review data, perform and troubleshoot assays, and contribute to method qualification and projects, with some overtime as required by business needs.