QC Microbiology Sr Associate I - Lab Leadership and Impact

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

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Fitness & Wellness programs

Paid vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a QC Microbiology Sr Associate I to support microbial testing of in-process materials, EM/UM, and raw materials at our RTP drug substance facility. You will lead key QC lab operations, train teammates, and participate in method qualifications and projects.

The role emphasizes data integrity, strict adherence to SOPs, and cross-functional collaboration with manufacturing and facilities teams. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor’s degree in microbiology, biology, or related field.
• Minimum 4 years in pharmaceutical microbiology and GMP manufacturing.
• Familiarity with LIMS and electronic notebooks.
• Knowledge of bioburden, endotoxin, environmental monitoring, and aseptic techniques.
• Experience with document control and editing technical documents.
• Ability to apply basic statistics to trend analysis.
• Must meet cleanroom and aseptic gowning requirements.
• Excellent written and verbal communication; proficient in MS Word/Excel.

Responsibilities

• Review test data in LIMS.
• Prepare quarterly EM/UM reports.
• Support testing for qualification and study-directed work.
• Troubleshoot complex assays.
• Perform microbiology testing (bioburden, endotoxin, plate reading, ID).
• Conduct routine Environmental Monitoring in controlled areas.
• Collect and process utility and gas samples.
• Comply with SOPs and controlled documents with minimal supervision.
• Maintain lab cleanliness, equipment readiness, and inventory.
• Perform investigations (lab deviations) and follow safety policies.
• Work overtime as needed and perform other duties.

Skills

LIMS experience

Bioburden testing

Endotoxin testing

Environmental monitoring

Aseptic techniques

Document control

Statistical data analysis

Data integrity and quality

Microsoft Word & Excel

Strong written and verbal skills

Team collaboration across functions

Education

Bachelor’s in Microbiology, Biology, or related field

Tools

LIMS

Electronic notebooks (ELN)

GMP documentation tools

Veeva, Kneat (preferred)

Job description

Biogen is seeking a QC Microbiology Sr Associate I to support microbial testing of in-process materials, EM/UM, and raw materials at our RTP drug substance facility. You will lead key QC lab operations, train teammates, and participate in method qualifications and projects.

The role emphasizes data integrity, strict adherence to SOPs, and cross-functional collaboration with manufacturing and facilities teams. Strong communication and problem-solving skills are essential.