As a Senior Manufacturing Specialist II, your primary role involves providing technical and scientific support on the Downstream manufacturing shopfloor. You'll ensure the timely completion of manufacturing activities, including compliance, troubleshooting, and campaign preparation. Coaching Manufacturing Associates in your area of expertise is a key focus. Additionally, you'll oversee intra, cross-site, and cross-functional projects related to process and productivity improvements. Your responsibilities include managing recipe-driven operations, process equipment, deviation management, changeover, tech transfer, projects (change control and CI), and direct process support.

What You’ll Do 

• Act as Subject Matter Expert on manufacturing equipment and processes. Participate in Tech transfer activities as needed. Author related technical instructions and records, including RG/RT, procedures, work instructions, and forms.
• Partner with direct manager to assign appropriate resources to tech transfers, drive continuous improvement, ensure manufacturing instructions are clear, safe, and compliant. The incumbent can be both a people manager (Effectively lead and coach direct reports to meet career goals and business objectives and address human resource development opportunities and challenges) as well as individual contributor with respect to technical instruction management for specific portions of a manufacturing process.
• Initiate, own, and manage Manufacturing focused Change Controls, CAPAs, and Planned Exceptions. Support in generating area assessments and performs root cause investigations in DEV/AA/RAR reports in Trackwise.
• Utilize depth of experience and known precedent to identify, troubleshoot, and resolve moderately complex technical and operational problems that arise.
• Create projects as needed to establish new manufacturing techniques to resolve day to day issues with management guidance and cross-functional buy-in.
• Proactively identify continuous improvement opportunities, share knowledge cross functionally, and drive site and/or global implementation. Serve as CI Practitioner role when required by cross-functional teams.

Who You Are 

You are a highly skilled professional with expertise in manufacturing/technical processes and a deep understanding of scientific principles. Your analytical skills make you adept at troubleshooting and investigations. You excel in taking the lead on operational initiatives and projects, requiring minimal supervision. Your impact extends across multiple business units, showcasing your ability to navigate diverse organizational landscapes with a dynamic blend of technical acumen and leadership capabilities.

Required Skills 

• High school diploma or equivalent as a minimum. Bachelor’s degree or higher preferred. Other combinations of education and experience can be considered.
• 8 years direct experience working in a GMP environment
• Proficient in effective cross-functional team collaboration within the organization.
• Exceptional attention to detail and documentation skills.
• Coaching and training expertise in Manufacturing-related activities.
• Deputy function for MTO Manager role.
• Extensive knowledge of business and manufacturing processes to support operations.
• Advanced proficiency in Manufacturing Systems (DeltaV, Syncade, SIMCA, PI, Oracle, TrackWise, etc.).
• Strong understanding of basic QA and cGMP principles.
• Advanced technical writing skills.
• Proficient in Microsoft Office applications.

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