Job Description

What You’ll Do  

• Work in and help maintain a safe working environment 
• Perform and monitor critical downstream processes 
• Help maintain cleanliness and audit readiness of process area 
• Perform and document cGMP activities according to standard operating procedures, solution lot records and batch production records 
• Perform in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, etc.) 
• Purification steps using flow-through and column capture chromatography 
• Perform Bulk Fill/ Dispensing using Aseptic technique 
• Buffer preparation and production support activities (COP, Autoclave, etc.) 
• Perform column packing and qualifications 
• Effectively contribute in a dynamic team environment

Who You Are 

If you are a highly detailed, focused individual that enjoys problem solving and team work, you are a great fit for our manufacturing 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.  

Qualifications

Manufacturing Associate II: 

• High school diploma (or equivalent) in addition to 6 months of direct experience/1 year of related experience OR 
• BioWork Certificate, Associate’s Degree, or Bachelor’s degree with limited to no experience 
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds 
• Capable of working twelve (12) hour shifts or others assigned by management

Manufacturing Associate III: 

• High school diploma (or equivalent) in addition to 1.5 years of direct experience/3 years of related experience OR 
• BioWork Certificate or Associate’s Degree in addition to 1 year of direct experience/2.5 years of related experience OR 
• Bachelor’s degree with 6 months of direct experience/2 years of related experience 
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds 
• Capable of working twelve (12) hour shifts or others assigned by management

EXPERIENCE REQUIREMENT FOR ALL MANUFACTURING ASSOCIATES:

• Targeted biopharmaceutical training (Bioworks or equivalent) and/or related military training preferred
• Detailed oriented with excellent documentation skills
• Operates in a safe manner in order to avoid injury to self and others
• Strong peer and team leadership skills.
• Adaptable to changing needs and demands, comfortable navigating in a changing environment
• Comfortable with ambiguity; quickly understands the needs based on the situation at hand
• Influencing and leading a positive attitude throughout team
• Ability to communicate clearly and effectively to all levels of the organization
• Ability to interact with others in a professional and courteous manner in accordance with Biogen’s Core Behaviors

Additional Information

In Purification, we perform critical downstream processing activities within Current Good Manufacturing Practice (cGMP) cleanroom suites at our Research Triangle Park (RTP) facility. These processes include Buffer Preparation, Column Chromatography, Viral Filtration, Ultra Filtration and Bulk Dispensing of the drug substance. Our Manufacturing Associates must be flexible and demonstrate learning agility to perform a variety of complex tasks to produce both clinical and commercial products in a fast-paced environment. This position provides value to our organization by ensuring precise manufacturing of our life-changing therapies. This includes manufacturing therapies for multiple sclerosis, alzheimer’s disease and more. This manufacturing role supports the overall supply chain that delivers our therapies to the patients that need them. Our supply chain was recently listed by Gartner as a ‘Top 25 Supply Chain.’ This Manufacturing Associate position requires a willingness to work evenings and weekends to accommodate production schedules.