Principal Scientist, Biotherapeutic Bioanalysis
My client seeks an experienced PhD scientist with expertise in bioanalysis of biotherapeutic drugs to join my client’s DMPK group. This group conducts and outsources pharmacokinetic (pk) and immunogenicity assessment of protein-based drugs. As a senior member of the lab, the ideal candidate will manage the development and validation of ELISA- and MSD-based immunoassays and use these methods to analyze non-clinical and clinical study samples on anti-drug antibody and immunogenicity assays. The ideal candidate will also play a critical role dealing with bioanalytical challenges and helping to implement strategies for the overall success of biotherapeutic drug development. The Principal Scientist will mentor junior lab members by assisting with experiment planning, troubleshooting, and data review and interpretation. The Principal Scientist will also manage bioanalytical support (both pharmacokinetic and immunogenicity analysis) at external vendors.
The ideal candidate will take on the following responsibilities:
--Develop, validate and implement pharmacokinetic and ADA assays in support of non-clinical and clinical studies
--Implement regulatory guidances for bioanalytical assays and maintain GLP/GCP compliance
--Contribute to project goals by troubleshooting bioanalytical challenges and implementing new approaches and technologies, as appropriate
--Manage and mentor scientific staff including experiment planning, troubleshooting and data review for junior scientists
--Monitor CROs for outsourced projects
--Utilize a LIMS system for compliant control of sample tracking, sample analysis, and data generation and archival
--Contribute to technical reports and present results at periodic review meetings
Requirements:
--PhD degree in Immunology or a related field plus at least 5 years of experience with biotherapeutic bioanalysis.
--Managing biotherapeutic bioanalysis projects and laboratory staff in a GLP/GCP environment is requires.
--Significant experience developing anti-drug antibody assays and implementing associated regulatory guidelines is strongly preferred.
--Demonstrated success in leading bioanalytical programs through development is highly desirable.
--The successful candidate will be highly motivated with the ability to overcome challenges, develop and implement effective strategies and quickly adapt to new responsibilities.