In this Manufacturing Specialist role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

What You’ll Do:

• Acts as Subject Matter Expert on manufacturing equipment and processes within limited scope assisted by senior team members.  Authors related technical instructions and records, including Master Production Records, Solution Lot Records, procedures, work instructions, and forms.
• Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
• Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions
• Project management and project execution – lead or participate in projects (moderate to complex in nature), facilitating timely execution.
• Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
• This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.

Who You Are:

If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives. 

Manufacturing Specialist I

2+ years relevant experience in addition to a Bachelor’s degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience

Manufacturing Specialist II

4+ years relevant experience in addition to a Bachelor’s degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience

Preferred Skills:

• Prior experience in manufacturing – Drug substance Cell Culture, Purification, or Harvest/Cell Clarification.
• Understanding of business processes and roles of cross-functional groups supporting manufacturing operations.
• Robust understanding of quality and cGMP principles.
• Fundamental knowledge of change control in cGMP environment.
• Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
• Intermediate to advanced level of technical writing skill.
• Ability to interpret manufacturing process design documentation.

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.

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.