As a CMC purification development scientist, you will independently design, execute, and interpret experiments to develop robust, phase-appropriate purification processes for drug substance GMP production to enable human clinical studies and eventual licensure.
- Develop, optimize, and scale up purification processes for monoclonal antibodies, multi-specifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process development
- Support transfer of purification processes to GMP manufacturing sites for clinical material production, including preparation of technical documentation
- Evaluate novel, advanced bioprocess technologies that are in line with the group’s strategy
- Plan and execute laboratory and scale-up activities efficiently, collaborating within the team and cross-functionally to meet project timelines and goals
- Work with contract laboratories to plan and execute assigned viral clearance studies, interpret results, and contribute to technical documentation
- Bachelor’s degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field
- Master’s degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field
- Nice to have: resin chromatography (affinity, CEX, AEX, MMC)
- Nice to have: depth filtration
- Nice to have: virus filtration
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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