Process Engineer (downstream)

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

Alpine Immune Sciences is seeking a highly motivated individual to join the CMC team as a Process Engineer (Downstream). This individual will be part of a team working to design and develop downstream processes that are robust, scalable, well characterized, and economical for clinical and commercial manufacturing. The successful candidate should have experience in downstream process development and/or scale up of downstream manufacturing unit operations and will interact with Alpine’s network of external CDMOs. This is a Hybrid role that will be based out of our Seattle, WA office.   Duties and responsibilities:   • Apply a fundamental understanding of purification operations, including chromatography, ultrafiltration/diafiltration, viral inactivation, and viral filtration to support technology transfer and scale-up of clinical/commercial manufacturing processes. • Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale. • Work with external vendors (CDMO) and provide guidance in solving process issues. • Provide floor support/person-in-plant for manufacturing activities during development and GMP campaigns (travel may be required). • Perform lab-scale purification using AKTA systems. • Experience with statistical Design of Experiments and/or Quality by Design. • Experience with risk assessments and technical documents, including protocols and reports. • Participate in cross functional teams and represent Downstream CMC.   Qualifications:   • B.S. (M.S./Ph.D. a plus) degree in an Engineering or Scientific field with 4 or more years of industry experience in purification process development, characterization and/or manufacturing. • Experience scaling-up purification unit operations, with an understanding of cGMP requirements, FDA, and ICH guidelines. • Possess an in-depth understanding of unit operations used for downstream processing of biologics. • Excellent written and verbal communication skills. • Work well independently and in teams in a highly dynamic, cross-disciplinary environment.

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