Sr Associate I, Quality Control Microbiology at External — Research Triangle Park, NC

Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours.

About This Role

We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned.

What You’ll Do

• Review test data in LIMS
• Prepare quarterly EM/UM reports
• Supports testing for all qualification and study directed testing
• Troubleshoot complex assays
• Perform microbiology testing (e.g. Bioburden, Endotoxin, plate reading, and microbial identification) following standard procedures
• Conduct routine Environmental Monitoring (viable and non-viable) in controlled manufacturing areas
• Collect and process utility and compressed gas samples
• Comply with SOPs and controlled documents under minimal supervision
• Maintain laboratory cleanliness, equipment readiness, and inventory
• Perform investigations (i.e. laboratory and deviations)
• Follow site safety and contamination control policies
• Work overtime as required by business needs
• Perform other assigned duties

Who You Are

• Someone who demonstrates strong attention to detail and analytical skills, along with a solid commitment to maintaining data integrity and quality
• You possess a collaborative approach and work effectively across manufacturing and facilities teams

Required Skills

• Bachelor’s in Microbiology, Biology, or related field
• Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing
• LIMS experience, including using electronic notebooks
• Demonstrated knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring), aseptic techniques, and general laboratory techniques
• Experience with document control including reviewing and editing technical documents
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Able to follow procedures and complete technical tasks
• Can meet cleanroom and aseptic gowning requirements
• Physically able to stand long periods, bend, move carts, and lift 25 lbs
• Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel
• Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines

Preferred Skills

• Advanced knowledge of Microbiology testing and Microbiology theory
• Prior experience in utilities monitoring, including gas monitoring
• Prior training experience, including classroom training
• Proficient in using LIMS systems, Veeva, Kneat, and Microsoft software
• Knowledgeable in GMP, GLP, and GDP requirements
• Advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
• LEAN lab and Six Sigma training and/or certification
• Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
• Experience performing EM/UM excursion investigations

The base compensation range for this role is: $81,000.00-$105,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?