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Associate Scientist/Eng. I/II - Downstream Process Development

Company: Paragon Gene Therapy, a unit of Catalent Biologics
Location: Baltimore
Posted on: August 21, 2019

Job Description:

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Associate Scientist/Engineer I/II is actively engaged in process and product development within a dynamic team and displays strong technical knowledge, initiative, and scientific commitment, and makes significant scientific and technical contributions to downstream process development.Key Responsibilities Include, but are not limited to:

  • Integral team member in moving projects forward toward GMP Manufacturing for clinical trials, registration, improvements of existing processes and products
  • Participates in decision-making processes within the project team by actively engaging in scientific and technical discussions
  • Performs work encompassing different projects and programs including:
    • Downstream process development of recombinant protein, virus-like particle, and virus purification processes
    • Primary recovery from cell paste or inclusion bodies of specific proteins/macromolecules
    • Downstream processing of macromolecules expressed in mammalian cell lines, insect cells, or microbes
    • Development and execution of purification and analytical protocols
    • Interaction with appropriate members of upstream and analytical functional areas for purification and analysis of target molecules
    • Interaction with appropriate members of quality for review of documentation
    • Deploys knowledge and technical skills to independently design and execute studies
    • Builds credibility within group by performing high quality work
    • Expands the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform or systems development, or using a literature precedent
    • Teaches others in their area of expertise, and assists with work being performed by other members of the Downstream Process Development group
    • Documents and effectively communicates results of individual executed work through summary presentations, discussions with supervisor, and scientific meetings on a regular basis.
    • Possesses considerable knowledge and expertise relating to protein purification and analysis and other fundamental lab technologies or platforms Education & Experience:
      • AS I - Bachelor of Science in a life science or chemical engineering field plus 0-3 years experience
      • AS or Eng II - M.S. in a life science or chemical engineering field plus 0-3 years experience OR B.S. in a life science or chemical engineering field plus 3-5 years experience with chromatography based processing methods such as Affinity, Ion Exchange, Hydrophobic Interaction, and Size Exclusion is required as is column packing.
      • Analytical techniques: Gel Electrophoresis (SDS PAGE Gel), Western Blotting, HPLC, Bioactivity assays, Colorimetric Protein assays, and Spectroscopic Measurements required
      • Knowledge of how GMP regulations impact process development of biologics products
      • Demonstrated familiarity with AKTA chromatography systems and UNICORN software is strongly desired
      • Familiarity with instrument care, maintenance, troubleshooting, and data interpretation
      • Experience with filtration processing using Crossflow or Tangential Flow Filtration techniques is a plus
      • Understanding of protein biochemistry (protein folding, protein degradation, aggregation, etc.
      • Ease with document writing, data interpretation, presentation skills, and statistical analysis
      • The ability to work in team oriented environment is essential, as this person will work closely with other members of Process Development Group, QC, GMP, and participate on multidisciplinary project teams
      • Previous experience working in Biotechnology or Pharmaceutical industry considered a plus. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

Keywords: Paragon Gene Therapy, a unit of Catalent Biologics, Bowie , Associate Scientist/Eng. I/II - Downstream Process Development, Engineering , Baltimore, Maryland

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