About This Role

As Quality Control Senior Manager Microbiology, you will be responsible for the Micro & EM/UM department, which includes:

• Lead a team of skilled microbiologists and analysts, providing mentorship and guidance to ensure accurate and timely microbiological testing of raw materials, in-process samplesdrug substances, as well as environmental and utility samples.
• Develop and implement microbiological testing methods, procedures, and protocols for environmental monitoring, utility testing, and product analysis in alignment with industry regulations and company standards.
• Oversee the qualification, calibration, and maintenance of microbiology laboratory equipment and instruments used forenvironmental and utility monitoring.
• Monitor and assess microbial trends and deviations in environmental and utility samples, implementing corrective actions and continuous improvement initiatives as necessary.
• Collaborate cross-functionally with R&D, Quality Assurance, and manufacturing teams to address any quality-related concerns and ensure a seamless product lifecycle, including contamination prevention strategies.
• Provides troubleshooting for personnel, leads investigations in case of rapid identity failing,
• Author of investigational protocols, investigational reports, change control requests and validation/qualification protocols and reports.
• Interactions with Regulatory, Main Subject Matter Expert during GMP Audits from agencies & partner firms

Who You Are

We are seeking a dedicated and experienced individual to lead our cross-functional microbiology team. This position holds immense potential to make a significant impact within our organization. As the team lead, you will play a pivotal role in transforming our siloed team into a cohesive and high-performing unit that thrives on communication, transparency, and shared success. You are a dynamic and results-driven professional with a proven track record of driving success in a collaborative and transparent team environment.

Required Skills

• Bachelor's, Master's, or Ph.D. degree in Microbiology, Biology, or a related field.
• Minimum of 10 years of progressive experience in a microbiology-focused role within a regulated industry (e.g., pharmaceuticals, food, cosmetics), with a strong emphasis on environmental and utility monitoring.
• Proven experience in managing and leading teams, fostering a collaborative and growth-oriented environment.
• Thorough understanding of current Good Manufacturing Practices (cGMP) and regulatory requirements related to microbiological testing and environmental monitoring.
• Experience in BLA submission
• Strong analytical skills and the ability to interpret complex data sets, particularly in the context of environmental and utility monitoring.
• Excellent communication skills to effectively liaise with cross-functional teams and present findings to upper management.
• Demonstrated problem solving skills, ability to multi-task operations, working autonomously and cross-functional

This is a rare opportunity to lead a team that's on the cusp of transformation and growth. If you're a proactive, analytical, and collaborative individual with a passion for driving results and making a tangible impact, this is the right opportunity for you.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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