As a member of the Manufacturing Science & Technology group in Process Development department, this individual will join a group of process scientist and engineers to support downstream processes of commercial productions and late stage clinical process development and productions. The scope of work will include designing studies under instruction, executing experiments and data analysis to support GMP investigations and manufacturing change controls and to reduce reoccurring deviations. The focus of the work will be downstream unit operations such as column chromatography, harvest clarification, TFF and normal flow filtration. This individual will interact with other PD groups and other departments including manufacturing, PTS, QC, QA and Engineering etc.
BS degree in Chemical Engineering, Biochemistry/Protein Chemistry or related disciplines with 0-3 years of relevant experience in a biotechnology/pharmaceutical environment is required.
Experience with column chromatography and TFF is required. Knowledge of the quality systems and other regulatory requirements necessary to manufacture biologics in a cGMP environment is preferred.
The successful candidate must:
•Have hands-on downstream process development experience
•Be able to learn to work independently and on cross-functional teams
•Have good written and verbal communication skills
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