Job Description

The Coordinator III, Manufacturing role supports the RTP Small Scale Manufacturing (SSM) Organization. Responsibilities include: coordinating changeover activities for manufacturing areas, assisting with authoring and revising standard operating procedures (SOPs), management of hoses, coordinate movement of equipment between manufacturing areas and offsite warehouse, and serve as the team’s representative to various cross-functional projects and human performance/continuous improvement initiatives.

What You’ll Do

• Changeover: Coordinator will work with manufacturing, engineering and quality to facilitate changeover of a manufacturing area. Use Kneat to draft, review and approve electronic protocols. Use LIMs to generate sample labels and summary reports. Author/revise SOPs and perform SME assessments for GCCs as needed.
• Hose management: Coordinator will work with manufacturing, engineering and external vendors in procuring hoses. Use CMMS to onboard new hoses, monitor hose expiry and withdraw/retire hoses that are expired or no longer in use.
• Equipment Movement: Coordinator will work with manufacturing, engineering and warehouse to facilitate movement of equipment between manufacturing factories or to and from the offsite warehouse. Use CMMS to update equipment status and location.
• Team Representative: Participate in meetings that may require support from the Manufacturing Coordination Team (ie. daily integrated working team meetings, Fit-For-Manufacturing (FFM)/Invasive PMs meetings, GCC Review Board (CRBs), Tech Transfers, Facility Shutdown Planning,etc.)
• Human performance: Use Devonway to review open reports, workflow interrupters and continuous improvement ideas submitted by manufacturing. Coordinator may also provide support with implementation of continuous improvement ideas.

Who you are

You have a developing understanding of the manufacturing process, including manufacturing support activities. You have a good base of technical knowledge, including understanding relevant engineering and scientific concepts as well as basic biotechnology process.

Qualifications

Required skills

• • Associates Degree or Bioworks Certificate and 6 months of transferrable Experience
• High School Diploma (or Equivalent) and 1 year of transferrable experience
• Possesses a base understanding of the manufacturing process, including manufacturing support activities.
• Understands the basic theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities.
• Must be able to demonstrate the ability to work under the supervision of a senior team member
• Understands basic biotechnology processing – purpose of major unit operations and microbial control concepts
• Good verbal and written skills are required to ensure proper description of any issues.
• Ability to work with relevant electronic systems.

Preferred Skills.

• Recognizes potential process and equipment problems.
• Understands implications of test/process specifications, operating ranges, alert and action limits.
• Writes new and edits existing documentation.
• Experience with assisting in minor deviations during changeover process (investigations, Remedial action reports,)
• Understanding of investigative techniques related to deviations in manufacturing
• Experience with Kneat, LIMs, MyCims, CMMS (Infor), Microsoft Office (Word, Excel, Project)

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.