Job Description About This Role
In this role, you will lead and oversee a team of Manufacturing Associates, coordinate shift tasks, and ensure a commitment to cGMP compliance and safety procedures. You will play a pivotal role in maintaining updated manufacturing documentation and serve as a system expert, leading technical issue resolution and troubleshooting while actively representing Manufacturing (MFG) in cross-functional teams. Additionally, you will be responsible for the management and development of your direct reports.
What You’ll Do
Collaboratively schedule and direct daily manufacturing activities, promptly communicating scheduling changes and addressing issues with your team and management.Execute manufacturing activities in strict accordance with cGMP standards, ensuring the successful completion of batch execution. You will evaluate test results, identify and resolve issues, and expertly troubleshoot manufacturing equipment, including analytical instruments, providing recommendations for resolution. Coordinates and drafts revisions to automated batch documents.Coordinate and contribute to the drafting of revisions for automated batch documents.Prioritize diversity and inclusivity while hiring and developing a high-performing team, with a strong focus on promoting shared values and culture.Establish goals and development plans for employees, nurturing their professional growth.Provide comprehensive training to Manufacturing Associates, encompassing process activities, safety procedures, and CGMP requirements.Supervise validation activities, ensuring the proper and timely execution of validation protocols within your designated areas.Foster seamless collaboration by coordinating manufacturing activities with other departments and sites, maintaining open communication with production schedulers, and closely collaborating with quality assurance, materials management, manufacturing science, validation, facilities, process engineering, and more. Qualifications
Who You Are
You excel in a dynamic work environment with tight deadlines, demonstrating a meticulous attention to detail. Your commitment to making a positive impact drives your dedication to collaborative problem-solving. You appreciate diversity and inclusion as integral components of a successful team.
Required Skills
Possess a minimum of 7 years of solid practical experience with similar responsibilities, preferably in pharmaceutical processing within a manufacturing or process development environment, particularly in the biotech or pharmaceutical sectors.Hold a BS degree in Biotech or Pharmaceutical Science or possess a relevant educational background from the chemical industry, food industry, pharmaceutical, or biotech sector.Demonstrate practical knowledge of cGMPs and a deep understanding of biotech/pharmaceutical production processes and unit operations.Managerial experience is essential.Display moderate to advanced knowledge of various processing equipment.Exhibit a solid grasp of the engineering and scientific principles relevant to your areas of responsibility.Possess effective communication skills suitable for engaging with individuals at all levels and demonstrate proficiency in English and/or German languages. Additional Information
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