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Manufacturing Associate III – Purification / Downstream

Biogen

Manufacturing Associate III – Purification / Downstream

National
Full Time
Paid
  • Responsibilities

    Job Description

    ABOUT THIS ROLE

    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.

    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

    Qualifications

    REQUIRED EDUCATION / EXPERIENCE

    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

     

    REQUIRED SKILLS

    • 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
    • Capable of working twelve (12) hour shifts or others assigned by management

    PREFERRED SKILLS

    • Targeted biopharmaceutical training (Bioworks or equivalent) and/or experience in a regulated environment or military training
    • 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).
    • Proficient in Window based software and the ability to adapt to changing software programs

    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.

  • Industry
    Manufacturing