Kodiak Sciences is a rapidly growing clinical-stage biotechnology company with a focus in ophthalmology. The Scientist will join our Chemistry, Manufacturing, and Controls (CMC) team with a focus on process development. The candidate will be part of a team responsible that drugs being manufactured are safe, effective and of a high quality for patients. We are looking for a highly motivated, independent, and skilled protein scientist. The primary role is to design and execute laboratory experiments for biological intermediates and drug substance process development.
Responsibilities
- Plan and perform process development activities including mammalian cell cultivation, chromatography (resin and membrane) and filtration (NFF and TFF) experiments to develop a robust and lean antibody process fit for technology transfer to CMOs and clinical phase material generation.
- Plan and execute process characterization of biologics (monoclonal antibodies and/or antibody-biopolymer conjugates).
- Review cGMP documents (process validation, manufacturing records, deviations, and change requests), to ensure compliance with applicable regulatory and industry standards for phase appropriate cGMP manufacture of biological intermediates and drug substances at CMOs.
- Maintain laboratory operations and equipment, ensuring proper calibration and functionality. Manage inventory of laboratory chemicals and consumables.
- Support regulatory submissions by contributing to the preparation of documents such as INDs, IMPDs, and BLAs.
Education/Experience
- Master’s degree in Biochemistry, Biotechnology, or related discipline; Bachelor's degree with a minimum of 2 years of relevant experience in the biopharmaceutical industry.
- Hands-on experience and technical expertise in mammalian cell culture and/or separation and purification technologies such as tangential flow filtration and chromatography.
- Experience in conjugation of proteins and/or Design of Experiment (DOE) approach is a plus.
- Strong team player with a flexible and proactive attitude.
- Applicants must have the right to work in Switzerland.