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Scientist/Engineer, Upstream Process Engineering

Company: Alder Biopharmaceuticals
Location: Bothell
Posted on: June 15, 2019

Job Description:

Scientist/Engineer, Upstream Process Engineering Alder Biopharmaceuticals is seeking a highly motivated individual to join the Pharmaceutical Operations Process Engineering department. This position will be filled at a level commensurate with experience. This individual will ensure processes are robust, scalable, well characterized, and economical for commercial manufacturing. The successful candidate will interact with internal product development groups and with Alder's network of external CMOs/contract labs. Primary responsibilities may include designing process characterization studies, analyzing data using statistical analysis, and authoring reports to enable process validation for upstream processes. Specific responsibilities will include: Write protocols and reports to meet commercialization timelines Generate and implement design of experiments with subsequent statistical analysis of data Author regulatory sections for marketing authorization regulatory filings Perform on-site troubleshooting during process scale-up (international travel may be required). Interpret analytical results and write technical reports used as primary references for regulatory filings Represent process development on one or more internal project teams and also on CMO/external project teams to enable successful process validation Category: Science , Keywords: Pharmaceutical Scientist

Keywords: Alder Biopharmaceuticals, Seattle , Scientist/Engineer, Upstream Process Engineering, Engineering , Bothell, Washington

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