Senior / Principal Scientist, Upstream Process Development

Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.

We are seeking a talented Senior / Principal Scientist in developing CHO bioreactor process for production of biotherapeutics, with broad expertise, capable of contributing to both drug discovery and development projects. The position requires strong interest in bench work and deep background in cell line and upstream process development for biologics. Hands on bioreactor experiences working with multi-specific, fusion proteins are required.

Essential Duties and Responsibilities

• Lead and participate in upstream process development activities
• Ability to work in a high paced team environment, plan and meet timeline
• Responsible to prioritize work on multiple projects, support and closely work with other divisions to advance company goals
• Background of molecular biology in CHO expression vectors, genetically characterize cell line and analyze for sequence variants
• Responsible for process optimization and validation
• Develop research plans, design experiments, outline research procedures to be followed, and identify or provides training to subordinate personnel to carry out research.
• Knowledge of regulatory requirements. Write and review Standard Operating Procedures (SOP) and reports for regulatory filling.
• Establish relevant process transfer document and cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations.
• Work with R&D and manufacturing department in China. Plan time to accommodate meetings and technical support
• 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

• PhD with 3+ years, or a MS with 10+ years of experience in cell culture
• Experience with upstream process development is preferred
• Strong scientific understanding of recombinant protein expression in bioreactor, cell line development, cellular metabolism and media optimization
• Experience in early and late-stage biologic development is plus
• Excellent communication skills and a proven track record of IND filing, publications and presentations