Sr Associate I, Quality Control Microbiology

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

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

Tuition reimbursement

401(k) with company matched

Paid vacation and holidays

Job summary

Biogen in RTP, North Carolina, is seeking a QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at the drug substance manufacturing facility. The role leads key operational aspects of the QC Microbiology laboratory and trains others in microbial testing.

You will review data, perform and troubleshoot assays, and contribute to method qualification and projects, with some overtime as required by business needs.

Qualifications

• Bachelor’s degree in microbiology, biology, or related field required.
• Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing.
• LIMS experience, including electronic notebooks.
• Knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring) and aseptic techniques.
• Experience with document control and editing technical documents.
• Intermediate statistics knowledge to analyze data and trends.
• Ability to follow procedures and complete technical tasks.
• Able to meet cleanroom and aseptic gowning requirements.
• Strong written and verbal communication skills; proficient in Word and Excel.

Responsibilities

• Review test data in LIMS and prepare quarterly EM/UM reports.
• Perform microbiology testing (bioburden, endotoxin, plate reading, ID).
• Conduct environmental monitoring in controlled manufacturing areas.
• Troubleshoot complex assays and participate in investigations.
• Comply with SOPs and controlled documents; maintain lab readiness.
• Overtime as required; maintain inventory and lab cleanliness.

Skills

LIMS experience

Bioburden testing

Endotoxin testing

Environmental monitoring

Aseptic techniques

Documentation control

Statistical data analysis

Gowning & cleanroom

Written & verbal communication

Laboratory organization

Education

Bachelor’s in Microbiology, Biology, or related field

Tools

LIMS

Veeva

Kneat

Microsoft Office

Job description

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, 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

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. Read on to learn more about our Biogen.

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.