Associate Principal Scientist
- Collaborate with bioanalytical teams in US/UK for successful PK/IMG/PD immunoassay transfer, trouble shooting, validation, sample testing and data/result reporting.
- Design, execute and review experiments to support development and validation of new methodologies for PK/IMG/PD immunoassays for novel biotherapeutic modalities.
- Generate/record/analyze/report/archive data with a high level of integrity and ethics and ensure regulatory requirements (GLP/GCP) and industry practices are followed.
- Write method validation protocols/reports, bioanalytical sample testing reports and Standard Operating Procedures.
- Provide guidance and mentoring to junior lab members with experiment planning, troubleshooting, and data interpretation.
- Present results at team/department meetings, prepare controlled documents and study plans/reports, and contribute to regulatory submission documents.
- Manages resources and timelines to ensure timely delivery of results for clinical decision-making.
- Serve as a scientific monitor for oversight of outsourced PK/IMG/PD bioanalytical work at CROs.
- Independently apply basic scientific principles, attend scientific meetings, and keep abreast of cutting-edge techniques that can be implemented to enhance assay quality or throughput.
- Ph.D. Degree in Immunology, Biology, Biochemistry, Pharmacology or related field with 3+ years of industry experience in the field of regulated bioanalysis.
- Expertise in developing and troubleshooting fit-for-purpose immunoassays or ligand-binding assays (LBA) in some or all the following platforms: ELISA, MSD, cell-based assays, and flowcytometry.
- Experience with assay development, validation and/or sample testing for PK/IMG/PD in a GLP/GCP environment is highly preferred.
- Previous supervisory experience is a plus.
- Attention to details and strong organization/teamwork skills.
- Ability to overcome challenges, develop and implement effective strategies, quickly adapt to new responsibilities, and critically evaluate and interpret data.
- Excellent communication skills in an inter-disciplinary environment and capable of managing multiple projects with a high emphasis on quality and timelines.
- Proficient in both Chinese and English (both oral and written).
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.