Sr. Coordinator I, Manufacturing at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

This site-based role supports our ASO/OSD teams, primarily during core weekday business hours, but may require off-hours support.

The Sr. Coordinator I role provides leadership to manufacturing coordination and support activities with responsibilities involving material ordering and handling, as well as equipment coordination, batch record/documentation reviews and compilation, data mining and metric development, and manufacturing representation in cross functional projects and continuous improvement initiatives. This role also performs other manufacturing support functions, up to and including manufacturing operations and ownership of minor deviation investigations, as necessary, placing an emphasis on Data Integrity and Continuous Improvement.

What You'll Do

• Ensuring that all data generated through manufacturing activities is maintained, reviewed, analyzed, and assessed.


• Initiates, owns, and manages batch throughput analysis, product changeover, and data integrity remediation support.


• Owns and manages the review of executed documents to ensure compliance with cGMP.


• SME assisting QA & MFG teams in completing corrections for batch disposition.


• Leader within the GMP manufacturing processes by ensuring that manufacturing functions outside of general processing are completed in a timely manner and are performed consistently with the utmost quality and efficiency to ensure on-time and successful delivery of production schedules.


• Initiates, owns, and manages product changeover protocols, onsite/offsite equipment tracking, and batch material order coordination.


• Manages manufacturing owned materials (e.g., KANBAN, cycle counts, inventory management)


• Facilitates high impact Manufacturing projects (i.e., capital projects) and.


• Leading the manufacturing coordination team and partnering with Manufacturing Associates to improve manufacturing efficiency.

Who You Are

You are a detail-oriented coordinator, who leads multiple manufacturing projects at once, while delivering quality and support to your manufacturing teams supporting GMP manufacturing activities. Someone who provides guidance and leadership with teammates while also making an impact as an individual contributor.

Qualifications

Required Qualifications:

• B.S. degree (STEM preferred) plus a minimum of 3 years of transferrable experience OR
  


• Associates Degree (STEM Preferred) plus a minimum of 4 years of transferrable experience or


• HS Diploma/Certificate plus 5 years of transferrable experience.

Additional Requirements:

• Work independently and with minimal direction.


• Utilize technical experience, judgement, and precedent to identify, troubleshoot, and resolve technical and operational problems that arise in a GMP environment.


• Proactively identify continuous improvement opportunities, shares knowledge cross functionally, and drive site implementation.


• Develop schedules for the group when requested and keep other groups current on scheduling changes (e.g., communicates with schedules and materials management as required).


• Provide comprehensive and timely scheduling updates to the planning group(s).


• Effectively manages time with multiple projects/tasks, prioritizes tasks for self and for the team as required to meet production timelines. Fully understands project timelines, including start-up and changeover schedules.


• Prioritizes daily tasks and responsibilities to meet daily schedules.


• Judgment & initiative is required in resolving problems and making recommendations.


• Considerable knowledge of the detailed aspects of the job and their practical applications to problems and situations encountered in the manufacturing area.


• Basic understanding of subject processes, technology/science of functional area. Applies job skills and company policies and procedures to complete a variety of complex tasks.


• Requires the application of time management skills.

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.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.