Job Description

ABOUT THIS ROLE

Biogen is accelerating its capacity within gene therapy operations with the focused goal that one day we will help transform the way we treat neurological diseases. The Manufacturing Associate in Downstream for Biogen’s Gene therapy Manufacturing (GTM) Facility at Research Triangle Park (RTP) performs process steps such as buffer preparation, Column Chromatography, Viral Filtration, Ultra Filtration and Bulk Dispensing of the drug substance.  Our team is looking for a self-starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data recordkeeping.  

During the start-up of the facility the Associate contributes to creating SOPs, OJTs, and works alongside cross functional teams in the testing and qualification of equipment and facilities.

We prioritize the possession of a few soft skills in addition to technical experience, with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork, interpersonal skills for conflict resolution, teachability, patience, and willingness to follow procedures. Preferred technical skills include drafting procedures and starting up GMP operations, Bioworks or biomanufacturing training, and degrees in microbiology, engineering, biotechnology, or biology.

WHAT YOU’LL DO

• Work in and help maintain a safe working environment
• Perform and monitor critical downstream processes and troubleshoot operational and equipment problems
• Help maintain cleanliness and audit readiness of process area
• Perform, document, and review cGMP manufacturing activities according to standard operating procedures, solution lot records and batch production records, both paper and electronic.
• Purification steps using flow-through and column chromatography and TFF
• Perform in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, etc.)
• Perform Bulk Fill/ Dispensing using Aseptic technique
• Buffer preparation and production support activities

Qualifications

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. 

REQUIRED SKILLS

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

MANUFACTURING ASSOCIATE IV:

• High School Diploma (or equivalent) in addition to 3 years of direct experience OR
• BioWork Certificate or Associate’s Degree in addition to 2.5 years of direct experience OR
• Bachelor’s Degree with 2 years of direct experience

PREFERRED SKILLS

• Direct Gene Therapy experience highly preferred
• Targeted biopharmaceutical training (Bioworks or equivalent) and/or experience in a regulated environment
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Basic troubleshooting skills on Purification equipment and processes (Buffer Preparation, Column Chromatography, Viral Filtration, Ultra Filtration and Bulk Dispensing)
• Experience with process automation systems (i.e. DeltaV).
• Demonstrated knowledge of biomanufacturing process and equipment
• Excellent oral/written communications skills, analytical and organizational skills
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

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.