Senior Scientist, Downstream Process Development (Reading)

Compensation

: $102,855.00 - $169,240.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



Your Role:

Within the Biodevelopment Process Development group, you will be primarily responsible for developing purification processes for a variety of therapeutic candidate proteins including monoclonal antibodies and Fc fusion proteins. Scope of work will include, but are not limited to, protein purification, biochemical and biophysical characterization of proteins, novel purification technologies, purification process development, data analysis and project reporting. You will be responsible for execution of client project according to budget and timelines given to the project team.

  • Design fit-for-purpose purification experiments according to the stage of process development.
  • Ensure scientific evaluation of impact of deviations to Downstream validation studies.
  • Compile and analyze experimental data to generate process knowledge and decide on next steps.
  • Write development and validation reports and ensure their timely delivery.
  • Prepare and present project updates to global project team and to upper management.
  • Technical lead for Downstream process development, equipment and technologies; and troubleshoot experimental details.
  • Responsible for activities ranging from protein purification, filter sizing studies, biochemical and biophysical characterization of proteins (mAb, Fc-fusion, bispecifics and enzymes).
  • Execute routine protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software).
  • Perform analyses including but not limited to SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary.
  • Provide expertise and insight to guide development of appropriate purification methods.
  • Develop novel purification processes as well as using standard methods to purify proteins from 1 mg to 200 gram scale. Processes will be multiple steps and must provide necessary clearance of viruses, endotoxin, host cell proteins and DNA.
  • Perform, develop and optimize robust, efficient, scalable strategies for improving process performance. Activities will include small-scale studies and pilot scale purification studies.
  • Apply DOE methods to purification activities.
  • Who You Are:

    Minimum Qualifications:

  • Masters Degree in biotechnology or Life Science with 5+ years in the biopharmaceutical industry.
  • Solid and proven theoretical basis and hands-on experience in protein purification in process development and analytical characterization.
  • Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems.
  • Strong hands-on experience in troubleshooting and routine instrument maintenance.
  • Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography.
  • Knowledge and skills in biochemical characterization of proteins including analytical and biophysical.
  • Proven track record in Purification Process Development is necessary with emphasis on chromatographic separations and excellent understanding of and experience with chromatographic resin screening and process optimization.
  • Solid and proven working knowledge of DOE. Ability to critically analyze data using statistical tools and to compile technical reports.
  • Preferred Qualifications:

  • PhD in biotechnology or Life Science with 5+ years experience in biopharmaceutical industry.
  • Experience with scale-up and GMP manufacturing is desirable.
  • Excellent presentation and communication skills, both written and oral.
  • Results-oriented with ability to work and deliver under pressure.

  • Associated topics: aseptic, bacteria, bio, bioengineering, biology, genome, neurobiology, physical, stem cell, virus * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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