Job Description

The Global External Quality (GEQ) Batch Release team is responsible for the review and release of Finished Good, Drug Product and Drug Substance for Biogen to various markets around the world.  The Batch Release team is responsible for ensuring all batches are compliant with GMP standards and Regulatory Agencies.  This position reports into the US Commercial Release Team Lead.  The rest of the team is in Baar, Switzerland. 

The Product Quality Technical Services (PQTS) team is responsible for the strategic plans and implementation of stability and specifications for clinical and commercial Drug Substance and Drug Products manufactured at or for Biogen.  The team is responsible for ensuring all products have a stability strategy that can determine expiry/shelf-life and implementation of stability and specifications for a product into the Biogen systems.  This position reports into PQTS and the team is primarily located in RTP, North Carolina. 

POSITION DESCRIPTION 

You will work within the Global Quality organization attending meetings and participating in efforts to define strategies and standardization which are key to ensuring compliance and product availability in Biogen’s global markets.    

Example projects for this position include:   

• You will work with the GEQ group to lead the initiative to define Right First Time (RFT) and implement standardized practice to align US Contract Manufacturing Organizations (CMO) to track RFT metrics more accurately and standardize the release process.  You will gain valuable experience completing product mapping for all Finished Goods Commercial (FG COM) from CMO through Third Party Logistics and running pertinent metrics.  
• You will work with the PQTS group to support the implementation of a stability strategy for a program to include stability protocols, data analysis, data verification, and authoring stability reports.  You will gain valuable experience authoring stability protocols and reports, performing basic data analysis, and performing data verification.

Qualifications

To participate in the Biogen Internship Program, students must meet the following eligibility criteria: 

• Legal authorization to work in the U.S. 
• At least 18 years of age prior to the scheduled start date 
• Be currently enrolled in an accredited college or university

EDUCATION 

Applicant must be actively completing a bachelor’s degree (preferably in a science field) and have completed at least their first year of undergraduate degree.  This is not available to anyone that has already completed their undergraduate degree. 

Additional Information

All your information will be kept confidential according to EEO guidelines.