Associate Scientist / Sr. Associate Scientist - Downstream Process Development

Redmond, WA

Summary: The Associate Scientist/Sr. Associate Scientist will primarily work on downstream protein purification and characterization. The position will directly report to a Downstream Scientist and assist in downstream process development and tech transfer to GMP manufacturing facility. In this role the individual will assist and operate both routine, and advanced analytical instruments as well as protein purification systems.  

  

Essential Duties and Responsibilities:  

  • Support drug candidate optimization, selection, validation, and stability study throughout pre-clinical and clinical downstream purification development for antibody/protein.  

  • Support and closely work with research, cell-line development, upstream, analytical and formulation groups.   

  • Design and develop scalable and robust purification processes via affinity chromatography, IEX, HIC and CHT, etc.  

  • Design and develop scalable and robust viral inactivation, viral filtration and tangential flow filtration process.  

  • Generate low endotoxin production run for pre-clinical studies.  

  • Perform HPLC/UPLC, CE, octet and other biophysical techniques to support upstream and downstream process development.  

  • Perform and report interim analysis of accumulated data to monitor for the safety of the drug or procedure.  

  • Establish relevant process transfer document and cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations including Standard Operating Procedures (SOP) draft and review.  

  • Prepare reports and papers of completed projects for publication in technical journals, patents, presentation to regulatory agencies or at conferences, or use in further research activities.  

  • Plan time to accommodate meetings and technical support with analytical team members in China-based R&D center  

  • Participate in timeline planning and decision-making regarding research priorities of company or department and provide information on feasibility of prospective projects.  

  • Other duties as assigned.  

  

Qualifications:  

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

  

Education & Experience  

  • Ph.D.; MS; BS in Protein Science, Biochemistry or a related field (Ph.D., new graduates welcome); 5+ years (MS); 7+ years (BS) of relevant pharmaceutical or biotech experience  

  • Demonstrate a good understanding of protein purification mechanisms and protein analysis methodologies  

  • Ability to discuss experimental design and fully execute experiments independently from purification setup to analytical evaluation  

  • Hands-on experience in:  

    • Purification Process Development  

    • ÄKTA Protein Purification Systems and Unicorn software  

    • Crossflow and Tangential Flow Filtration techniques  

    • Column packing / unpacking  

    • Viral inactivation and viral filtration process development / Viral clearance study  

    • Low endotoxin production run  

    • Process scale-down/scale-up  

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