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.
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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.
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.
Qualifications
Possess a minimum of 7 years of solid practical experience with similar responsibilities, 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 both the German and English languages.
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.