Quality Control EM/UM and Contamination Specialist
Yesterday• Research Triangle Park, NC
This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required
About This Role
We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies.
What You'll Do
- Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices
- Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA Guidance)
- Partner with Manufacturing, Engineering, Quality Assurance, and Validation teams to assess and mitigate risks related to contamination control of product manufacturing
- Author and review SOPs, protocols, and technical reports related to EM/UM and contamination control
- Provide technical leadership in contamination control, risk assessments, and deviation investigations
- Support regulatory inspections and audits as the subject matter expert (SME) for EM/UM and contamination control
- Drive continuous improvement initiatives as it relates to contamination control
- Oversee the EM/UM trending and training programs
- Provide training and guidance on aseptic techniques and contamination control principles
- Other duties as assigned
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Who You Are
- A strategic thinker with a deep understanding of microbiology and contamination control in a GMP-regulated biologics environment
- Detail-oriented and analytical, with a strong commitment to data integrity and quality
- Comfortable making decisions in a fast-paced, dynamic environment
- A clear communicator who can translate complex microbiological concepts to cross functional teams and regulatory bodies
- Passionate about continuous improvement and innovation in contamination control
- Resilient and adaptable, with a proactive approach to problem-solving and risk mitigation
Required Skills
- Bachelor's degree in Microbiology, Biology, or related field (Master's preferred)
- Minimum 7-10 years of experience in pharmaceutical microbiology and sterility assurance within a GMP-regulated biologics or pharmaceutical manufacturing environment
- Minimum of 3 years of experience managing EM/UM and Contamination Control programs
- Strong knowledge of aseptic processing, cleanroom classifications/operations, and environmental and utilities monitoring programs
- Experience with regulatory inspections and audit readiness
- Familiarity with regulatory requirements including FDA, EMA, and ICH guidelines
- Proven leadership and team management skills
- Excellent communication, problem-solving, and organizational abilities
Preferred Skills
- Experience with biologics drug substance manufacturing (e.g., cell culture, fermentation, purification)
- Experience developing contamination control strategies
- Proficiency in risk assessment tools (e.g., FMEA, HACCP)
- Familiarity with statistical analysis and trending tools
Job Level: Management
Additional Information
The base compensation range for this role is: $109,000.00-$146,000.00
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
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 DE&I efforts.
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.
Client-provided location(s): Research Triangle Park, NC
Job ID: Biogen-REQ21907
Employment Type: FULL_TIME
Posted: 2025-11-05T00:04:41
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)