Scientist, Downstream

Position Summary

The Scientist in Downstream Purification and Conjugation is a key member of the Technical Operations team who will be involved in supporting Rakuten Medical’s research and discovery programs and CMC activities. The candidate will be pivotal for managing a team to develop clinical phase purification and conjugation processes in support of Rakuten Medical’s first-in-class photoactivatable monoclonal antibody conjugates. The Downstream team responsibilities include early and late phase process development and technical transfer, CMC support for drug substance and drug product manufacturing, and internal critical reagent material generation.

The candidate must demonstrate an ability to develop robust scale-up processes, establish control strategies, and coordinate early and late phase downstream regulatory requirements such as viral clearance validation, intermediate stability studies, process characterization studies, and process validation.  As a leader of the CMC organization the candidate should exemplify collaboration both cross functionally and with external organizations, foster innovation, and strive for the continual development and growth of the members of the Downstream organization.

Key Duties and Responsibilities: 

• With technical proficiency, the Scientist I should champion and execute technical strategies for the process development of therapeutic candidates from early-stage Phase I to late-stage Phase II and Phase III clinical trials through to commercialization
• Manage the bioprocess Downstream team in addition to cross functional collaboration with Upstream/Cell Culture, Analytical Formulation Development, Quality Assurance, and Regulatory for technical operations support of new and ongoing programs
• Coordinate the technology transfer of Purification/Conjugation processes (both process development and GMP scales) to external Contract Manufacturing Organizations
• Contribute to CMC sections in IND/BLA regulatory submissions and post-market support of commercial products
• Lead/manage purification/conjugation laboratory experiments including scale down studies, process characterization studies, validation studies, process range and robustness studies, and manufacturing troubleshooting activities of novel mAbs, proteins, conjugates, etc
• Experienced utilizing software for statistical analysis for screening DOE, Process Characterization to establish CPP and KPPs as well as the interpretation of results and reporting for regulatory inspection
• Stays current with latest scientific and engineering developments in the field
• Prepares technical reports, protocols, and routine presentations to cross functional teams and RMI management
• Business travel (US and X-US) to support manufacture and development activities.

Desired Education, Skills and Experience

• Strong Scientific and Engineering expertise with monoclonal antibody platforms, which includes column chromatography, and TFF/UFDF unit operations. Knowledgeable with recombinant proteins and analytical techniques related to area of expertise is preferred.
• BS with 12+ years of relevant industry experience or MS degree with 8+ years of relevant industry experience or advanced degrees in a relevant scientific discipline
• Experience leading downstream process transfer activities with CMOs and viral clearance validation studies
• Strong skills in statistical data analysis and process modelling, familiarity with JMP or similar software
• Excellent organizational skills and ability to meet deadlines with exceptional self-management ability with excellent verbal communication and interpersonal skills
• Experience with cGMP regulatory guidelines (FDA, EMA, PMDA, etc.) as related to development and manufacture processes
• Potential 5 – 10% travel required.