QC Microbiology Lead, Associate I

Biogen; Milwaukee (WI); On-site; USD 81,000 - 105,000; Full time

Benefits offered by this job

Cash bonus

Equity incentive

Paid vacation

Holidays & time off

Sick time

Maternity/Parental Leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Job summary

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

The position requires 4+ years of pharmaceutical microbiology experience, LIMS proficiency, and strong data integrity.

Qualifications

• Bachelor’s in Microbiology, Biology, or related field.
• 4+ years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing.
• Experience with LIMS and electronic notebooks.
• Knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring) and aseptic techniques.
• Ability to review and edit technical documents and control documents.
• Ability to analyze data and identify trends.

Responsibilities

• Review test data in LIMS.
• Prepare quarterly EM/UM reports.
• Supports testing for qualification and study directed testing.
• Troubleshoot complex assays.
• Perform microbiology testing (Bioburden, Endotoxin, plate reading, microbial ID).
• Conduct routine Environmental Monitoring (viable and non-viable).
• Collect and process utility and gas samples.
• Maintain lab cleanliness, equipment readiness, and inventory.
• Perform investigations (laboratory and deviations).
• Follow site safety and contamination control policies.
• Work overtime as required by business needs.
• Perform other assigned duties.

Skills

Attention to detail

Analytical skills

Collaborative

Strong written and verbal comms

Education

Bachelor’s in Microbiology or related

Tools

LIMS

Electronic notebooks

Veeva

Kneat

Job description

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

The position requires 4+ years of pharmaceutical microbiology experience, LIMS proficiency, and strong data integrity.