- Design fit-for-purpose purification experiments according to the stage of 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
- Ensure a continuous improvement within Downstream process development activities
- Represent & promote E2E and Biodevelopment activities (presentations, congresses, events)
- Technical lead on the overall projects (supervises Downstream processes development and implementation of new methods and services)
- Technical leader for equipment, technologies for Downstream process development
- Responsible for activities ranging from protein purification, filtration, biochemical and biophysical characterization of proteins: –
- 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
- To develop, validate and transfer robust analytical methods required for successful drug development and manufacturing.
- To support follow-up and troubleshooting on analytical methods.
- 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 the mg to gram scale. Processes will be multiple steps and must provide necessary clearance of viruses, endotoxin, and 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
- Engineering/Master degree (PhD preferred) in biotechnology with 5+ years in the biopharmaceutical industry
- Solid and proven theoretical basis and hands-on experience in protein purification 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. Experience with scale-up and GMP manufacturing is desirable.
- Solid and proven working knowledge of DOE. Ability to critically analyze data using statistical tools and to compile technical reports
- Excellent presentation and communication skills
- Results-oriented with ability to work and deliver under pressure
- Excellent English (written, oral)
All your information will be kept confidential according to EEO guidelines.
