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
Job Level: Professional
Additional Information
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.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
