Ability to work hands-on in a collaborative team environment.Excellent communications and presentation skills.Experience in cell-based assays, FACS, Biacore, and other modes of bioanalysis are a plus.Ability to prepare scientific assessments of nonclinical DMPK information for internal use and regulatory submission.Good knowledge of regulatory guidance such as US FDA, EMA and ICH specific to bioanalytical method development and validation of PK and Immunogenicity assay of therapeutic proteins.Hands on experience in developing and validating immunoassays for pharmacokinetic and immunogenicity assessment of therapeutic proteins using different assay platforms such as ELISA/MSD/Gyros etc.PhD in immunology, Biotechnology/Pharmaceutical sciences, biochemical engineering, biochemistry, biology, or related discipline with at least 3 years of industrial experience or MSc with at least 5 years of relevant experience.Perform other relevant duties as required.Evaluate external developments in the area of bioanalytical development and DMPK and make recommendations based on their applicability for Ichnos’ projects.Participate in project team meetings as assigned.Interpret and report results of work performed, in written and oral format, both internally and externally.Interact with various groups within Ichnos to understand assay requirements and propose/develop appropriate solutions.Support daily laboratory operations as required.To prepare bioanalytical contributing reports for the PK studies conducted in-house.

To support pharmacokinetic, PK/PD and exploratory toxicokinetic studies conducted in house and at CRO.

To work on innovative assays to support discovery and development projects.

To troubleshoot challenges faced in PK and ADA at CRO by conducting experiments in-house.

Provide support in monitoring bioanalytical activities out-sourced to CROs, including study planning and coordination, method transfer and validation, sample analysis and review of associated reports.Perform method technology transfer and qualification/validation as required.Conceptualize, develop, and adapt bioanalytical methods for preclinical and clinical pharmacokinetics (PK) and immunogenicity assessment (MSD, ELISA, cell-based assays) for Ichnos’ innovative biologics based on the proprietary BEAT® platform.

Sanitize solution biacore