Overview
To design, develop and validate fit-for-purpose custom pharmacokinetic and immunogenicity assays used in ImmTAC programs and conduct experiments to characterize in-vivo exposure, pharmacodynamic response and clinical impact.
Responsibilities
* Design and build custom LBA and/or cell-based pharmacokinetic and immunogenicity assays suitable for use in stage-appropriate clinical studies.
* Assist with PK modelling and simulations using software such as Phoenix and Biomath Assess. Working knowledge of R (and packages such as dplyr) would be advantageous.
* Lead technical transfer of validation-ready assays to suitable third-party laboratory vendors, and oversee method validation studies according to regulatory guidance and industry best practices.
* Monitor CRO assay performance and sample analysis; review and summarize PK and ADA results.
* Participate in clinical study teams as bioanalytical representative to coordinate sample collection, analysis and reporting according to established timelines.
* Design and execute exploratory bioanalytical projects; interpret data and make recommendations for next steps/future directions.
* Support preclinical studies as required to aid construct nomination and MOA investigations.
* Design and characterize custom reagents, controls and biological matrices for use in bioanalytical assays; effectively manage inventory of applicable study samples, reagents and controls.
* Keep abreast of technical advances in relevant fields through self-study and attending training sessions and conferences.
* Communicate results internally in lab meetings and seminars and externally in relevant conferences.
* Operate in accordance with the company's health and safety policies.
* Working knowledge and understanding of bioanalytical assays for protein macromolecules with strong scientific and technical skills in method development and validation.
* A minimum of 3 years of hands-on experience in the development and validation of quantitative immunoassays and immunogenicity assays for biologics (e.g. antibodies, proteins or peptides).
* Experience in aseptic cell culture and cell-based assay development.
* Familiar with current regulatory guidance and industry best practices for development and validation of bioanalytical methods for large molecule biologics.
* Experience in GLP and/or clinical regulatory compliance.
* Strong analytical skills, and a demonstrated ability to work both independently and in a team setting.
* Excellent verbal and written communication skills, PhD with 0-2 years of relevant professional experience in immunology, biochemistry or related discipline. Or MSc degree or BSc with equivalent, relevant experience.
#J-18808-Ljbffr