Immunomedics, Inc.

  • Senior Scientist, Downstream Process and Manufacturing Sciences

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(10/17/2019 11:33 AM)
    Job ID
    2019-1549
    # of Openings
    1
    Category
    Process Sciences
  • Overview

    Responsible for purification process development and validation of all commercial and clinical products under cGLP and cGMP guidelines.

    Responsibilities

    • Develops and optimizes purification processes for all commercial, clinical and preclinical products toward high yield and purity.
    • Expert knowledge of protein purification and analysis with an in depth understanding of modes of chromatography
    • Carries out small scale protein purification using column chromatography and TFF for product characterization studies.
    • Scales up and transfers purification processes for cGMP manufacturing.
    • Performs process validation (column reuse, virus removal, etc.).
    • Prepares SOPs, batch records, and technical reports, and maintains cGLP/cGMP-sound documentation.
    • Responsible for multiple areas of downstream validation including defining validation strategy, authoring and executing protocols, interpretation of data and generating final report
    • Independently executes purification studies including automated chromatography (AKTA platform), filtration, column packing and tangential flow filtration
    • Maintains documentation of experiments and/or protocols according to good documentation practices
    • Troubleshoots and problem solves in order to initiate and execute/monitor corrective actions
    • Maintain lab supplies and instruments; prepare buffers/reagents on an on-going basis
    • Must have excellent written and verbal skills with a demonstrated ability to work effectively in a team environment

    Qualifications

    • MS/ BS with at least 10 years relevant experience; or equivalent combination of education and experience
    • Experience with Downstream Manufacturing in a cGMP environment
    • Prior experience with automated chromatography platforms (e.g. GE Healthcare AKTA)
    • Experience with authoring and executing protocols, interpretation of data and generating final reports
    • Process scale chromatography and filtration (viral, tangential flow, normal flow) experience
    • Operating, maintaining, and troubleshooting chromatography work stations and process skids preferably in an industrial setting
    • Prior cGMP/GLP training and experience working in a cGMP/GLP environment required
    • Must be able to work in a team environment and perform job responsibilities under minimal supervision
    • Must be proficient with MS Office applications
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment. 
    • Detail oriented with strong aseptic techniques and the ability to follow SOPs required. 
    • Must be proficient with MS Office applications. 
    • Familiarity with cGMP regulations and conditions required. 

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