As the fully functional bioanalytical laboratory for R&D China, our mission in Development Science is to provide and ensure quality and compliant PK/PD/ADA/Nab/Biomarker data in a timely manner to support research and development of AZ clinical Projects and facilitate filing and marketing of AZ assets in China and beyond.

The Bioanalysis Associate or Scientist is responsible for:Serve as the proficient experimental technician in China biolab to perform all bioanalysis assays during method validation and sample analysis stages with high accuracy and precision.Strictly follow the GXP guideline and company SOPs, keep experimental records adhering to ALCOA+ principles.Finish data summary, report and transfer in a timely manner.Contributing to improvement of lab operation procedures.

Typical Accountabilities

Validate bioanalytical assays for the quantification of novel therapeutic proteins/ADCs, soluble targets, biomarkers, or the detection of anti-drug antibodies, fulfilling project requirements and complying with international guidance.Support clinical phase studies through planning of experiments and efficient conduct of sample analysis for timely delivery of bioanalytical data with good quality.Ensure accurate documentation of laboratory activities following regulatory requirements.Author and finalize method validation protocols/reports, bioanalytical sample testing reports.Promote an efficient, state-of-the-art, and GCP-compliant laboratory through continuous process improvement.Other tasks assigned by line manager.

Education, Qualifications, Skills and Experience

Essential

Degree level education or equivalent experienceExperience in pharmaceuticals or a related industryExcellent experimental skillsFluent in written EnglishHigh ethical standards, trustworthy, operating with absolute discretionStrong collaborative, influencing and interpersonal

Desirable

B.Sc. in Biology, Biochemistry, pharmacology or related field with 4+ (B.Sc.) years of hands-on experiences in the pharma/Biotech/CRO industryIndependent technical capability with assay development, validation, transfer and sample testing for PK/IMG/PD/Biomarker in a GxP environmentExpertise in developing and troubleshooting in some or all the following platforms: ELISA, MSD, cell-based assays, PCR and flow cytometry.Fluent in spoken English

Date Posted

04-12月-2024

Closing Date

30-3月-2025

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 authorization and employment eligibility verification requirements.