Job Description

In this Manufacturing Coordinator role (Large Scale Manufacturing), you will be responsible for manufacturing support tasks including writing investigations and data entry. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

WHAT YOU’LL DO:

The incumbent is highly detailed oriented with excellent documentation skills.

Responsibilities include but are not limited to:

• Performs area assessments and impact justifications for manufacturing related investigations such as Alert Actions (AA) or Remedial Action Reports (RAR)
• Ensures accurate and timely transcription of manufacturing process related data from paper records into electronic systems (PRIMR, KRAMER, etc.)

WHO YOU ARE:

• Possesses a basic understanding of the manufacturing process, including manufacturing support activities.
• Has basic technical knowledge, including understanding relevant engineering and scientific concepts.
• Possesses basic technical understanding of equipment function, application and procedures, and identifies potential process and equipment improvements. 
• Understands implications of test/process specifications, operating ranges, alert and action limits. 
• Able to apply understanding to avoid potential issues.
• Writes new and edits existing documentation.
• Understands basic biotechnology processing – purpose of major unit operations and microbial control concepts.
• Models the Biogen leadership values and behaviors.

Qualifications

COORDINATOR II

• 1-year related experience or 0.5 years of direct experience working in a GMP environment
• High School diploma or equivalent with 6 months direct experience OR
• Associates of Arts or Science degree or BioWork Certificate OR
• Bachelor’s degree, scientific discipline preferred

COORDINATOR III

• High School diploma or equivalent with 1.5 years direct experience or 3+ years of related experience OR
• BioWork Certificate or Associates of Arts and Science degree with a minimum of 1-year direct industry experience or 2.5 years related experience OR
• Bachelor’s degree, scientific discipline preferred, with 6 months direct experience or 2 years 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.
• Basic understanding of quality and cGMP principles.
• Intermediate skills in Microsoft Office and computer-based quality systems.
• Intermediate level of technical writing skill.

Additional Information

The Coordinator II/III, Manufacturing Coordinator role supports the RTP Bio Manufacturing Organization in ensuring that manufacturing functions related to data collection/analysis, assessments for manufacturing related investigations, process/continuous improvement projects and other items related to performance optimization in manufacturing are completed in a timely manner and are performed consistently with the utmost quality and efficiency.