Sr Associate I, Quality Control Microbiology
Biogen
Summary
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.
Job description
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
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Life insurance
- Fitness & Wellness programs
- Short- and Long-Term Disability
- 15 days paid vacation
- End-of-year shutdown
- 12 paid holidays
- 3 personal significance days
- 80 hours sick time
- Paid Maternity and Parental Leave
- 401(k) matching
- Employee stock purchase plan
- Tuition reimbursement up to $10,000
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.