Sr Associate I, Quality Control Microbiology

Regulatory Jobs; North Carolina; Presencial; USD 81.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision, Life ins.

Fitness & Wellness programs

Paid vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

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

Educación

Bachelor’s in Microbiology, Biology, or related field

Herramientas

LIMS

Electronic notebooks (ELN)

GMP documentation tools

Veeva, Kneat (preferred)

Descripción del empleo

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 planTuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.