Job Description

About This Role:

As the QC Site EM/UM and Contamination Specialist, you will be an integral member of our Quality Control operations team at RTP Bio. Your expertise will be pivotal in managing and enhancing the Environmental Monitoring (EM) and Utility Monitoring (UM) programs at our site. You'll take on the mantle of a microbiology subject matter expert during manufacturing contamination events, ensuring that our products meet the highest quality standards. Your role involves periodic reporting on EM/UM data trends and spearheading remediation and improvement actions. By leading the Environmental Review Board, you maintain a comprehensive sampling schedule and scrutinize results for significant trends, contributing to our site's exemplary regulatory compliance. In this position, you will act as a vital link between the site Quality Leader and the Site Leadership Team, escalating any contamination quality concerns. In essence, you are the guardian of our site's sterility assurance, fitting seamlessly into our business structure and adding tremendous value through your critical contributions to product integrity and safety.

What You'll Do:

• Oversee the full spectrum of the site's EM/UM program and serve as the microbiology expert for manufacturing contamination events.


• Engage in periodic analysis and reporting of EM/UM data trends to inform remediation actions and continuous improvement initiatives.


• Lead the Environmental Review Board, manage the sampling schedule, and review results for meaningful trends, including sub-alerts.


• Escalate contamination quality concerns and potential inspection risks to the site Quality Leader and Site Leadership Team.


• Collaborate with QC validation, transfer, and registration (VTR) personnel to ensure implementation of regulatory, cGMP, and industry practices.


• Lead site investigations and provide remediation recommendations related to contamination events.


• Prepare subject matter experts (SMEs) for site inspection readiness and participate in audits, including response to observations.


• Educate, mentor, and guide site quality personnel on contamination control, sharing findings and lessons learned.


• Partner with Manufacturing Sciences and the Learning Organizations to develop site training and qualification programs for aseptic operations.


• Contribute to complex projects such as site disinfectant studies and contamination investigations.


• Represent QC during inspections for EM/UM program and contamination investigation topics.


• Provide oversight and expert support for EM/UM samplers.


• Network within the industry to benchmark and identify best practices for optimizing site contamination control processes.


• Foster a strong quality culture, maintain open communications, and promote teamwork within the workgroup.

Who You Are:

You are a dedicated professional with a deep understanding of bioburden, endotoxin, and identity testing. Your knowledge of Annex 1 and site contamination control strategies is robust, and you contribute actively to complex projects and initiatives. In your career, you have honed your leadership skills and developed a keen technical understanding of contamination response from a compliance perspective. You stay current with technological and compliance developments in the industry. You are someone who values open communication, teamwork, and the importance of a strong quality culture in the workplace.

Qualifications

Required:

• Bachelor's degree (B.S.) in scientific discipline, preferably with a Master's degree (M.S.) or Ph.D.


• Minimum of 7 to 10 years of relevant experience in a GMP environment.


• Demonstrated experience with EM/UM program fundamentals, including testing, data analysis, trending, and contamination control measures.


• Strong understanding of and experience performing bioburden, endotoxin and identity testing


• Proven program leadership experience and the ability to guide and mentor cross-functional teams


• Technical knowledge and understanding of contamination response and compliance from a broad perspective.


• Up-to-date with current industry developments, such as Annex 1 interpretation.


• Strong communication and interpersonal skills.


• Strategic thinking with the ability to drive continuous improvement

Additional Information

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.