Job Description

About This Role

In this role, you will be responsible for leading a team of Manufacturing Associates, overseeing daily shift tasks, and ensuring compliance with cGMP standards and safety procedures. You will play a key role in maintaining and revising manufacturing documentation to ensure accuracy and compliance with industry regulations.

As a system expert, you will be the go-to person for technical resolution and troubleshooting, often representing the manufacturing team in cross-functional collaborations. Additionally, you will manage, mentor, and develop direct reports, fostering a productive and high-performing team.

What You’ll Do

• Schedule and direct daily manufacturing activities, timely communicating scheduling changes/issues to their staff and management. 
• Perform manufacturing activities according to cGMP. Ensure completion of batch execution.  Evaluate test results, identify and resolve issues. Troubleshooting manufacturing equipment including analytical instruments and is able to make recommendations for resolution 
• Coordinate and drafts revisions to automated batch documents.  
• Hire and develop a well-functioning team - focusing on values and culture. 
• Ensure establishment of goals and development plans for employees. 
• Train Manufacturing Associates on process activities, including Safety and CGMP requirements. 
• Supervise validation activities, ensuring proper and timely execution of validation protocols required in the areas. 
• Coordinate manufacturing activities with other department as well as other sites; provides updates to production schedulers and works closely with quality, materials management, manufacturing science, validation, facilities, process engineering etc. 

Qualifications

Who you are

You are a strong leader with a passion for excellence in manufacturing and a proven ability to drive results, this position offers a dynamic and rewarding opportunity.

Required skills

• Biotech or pharmaceutical BS degree or other relevant educational background from chemical industry, food industry, pharmaceutical or biotech industry
• Minimum 7 years solid practical experience with similar tasks, preferably with pharmaceutical processing in manufacturing or process development environment -within biotech, pharmaceutical.
• Practical knowledge with cGMP´s and understanding of biotech / pharma production processes and unit operations. Managerial experience is required.
• Moderate to advanced knowledge of most processing equipment.
• Solid knowledge of the engineering and scientific principles associated with their areas of responsibility
• Good communication skills with all levels and have good language skills in English.

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.