Kodiak Sciences is a rapidly growing clinical-stage biotechnology company specializing in ophthalmology. We are seeking a highly motivated, independent, and skilled analytical scientist to join our Chemistry, Manufacturing, and Controls (CMC) team. The successful candidate will focus on analytical method development and testing of biological samples, contributing to the release of high-quality and safe therapeutics for patients.
Responsibilities
- Plan and perform analytical testing of biological samples using techniques such as SoloVPE, CEX-HPLC, SEC-HPLC, RP-HPLC, icIEF, CE-SDS and kinetic chromogenic LAL endotoxin assay.
- Develop robust, phase-appropriate test methods and assays suitable for transfer to CMOs and for clinical phase material release.
- Review cGMP documentation (assay transfer or validation, deviations, and change requests), to ensure compliance with regulatory and industry standards for biological drug development.
- 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 analytical methods used for the characterization and release of biological drugs.
- Strong team player with a flexible and proactive attitude.
- Applicants must have the right to work in Switzerland.
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