2022 PhD & Post Doc - Senior Scientist, Large Molecule Bioanalysis (PCR)
Job Locations: Suzhou, China
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,800 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."
Responsibilities
- Serve as the expert in the development and validation of bioanalytical methods such as qPCR/ddPCR, flow cytometry to ensure newly developed and validated method for supported projects
- As laboratory technical supervisor:
- Support and responsible for the assay design and technical guidance of bioanalysis of preclinical gene cell therapy drugs independently
- Possess ability to select, design, develop and verify bioanalytical methods such as qPCR/ddPCR/FACS for different types of drugs, includes but not limited to select appropriate bioanalytical methods, design relevant primer probes independently, screening and optimization of primer probes/antibodies, optimization of the assay procedure, method development and validation
- Basic operation procedures of laboratory are clearly defined, complete the method development and verification in accordance with regulatory requirements
- Serve as laboratory supervisor, perform the training of gene cell therapy drug research and development knowledge to laboratory staff, provide technical guidance, support and training, ensure that the laboratory staff completed qualification certification and subsequent enrichment training
- Ensure that study personnel understand clearly their responsibilities and acknowledge relevant standard operating procedures
- Contingency plan is in place for unforeseen events that affects timeline and deliverables and the impact of any deviations from the study protocol and/or standard operating procedures on the quality and integrity of the study is assessed and recorded, and take appropriate corrective action if necessary
- Communicate effectively with the quality assurance personnel and deal with their findings during the conduct of the study
- Manage human resources, including screen, interviewing and selecting new hires to develop full capacity immunology team for study support
- Plan and provide regular trainings to staff to ensure adequate training is provided to staff to execute the required work assignments.
Qualifications
- Fresh PhD graduates or Master's degree with more than 3 years of work experience in biochemistry and molecular biology, cell Biology, pharmacy, immunology
- 2+ years of R&D experience in gene cell therapy drugs, with proficiency in at least two specialty areas in AAV drugs, oligonucleotide drugs (mRNA vaccines, ASO classes), exosomes, oncolytic viruses, CART, CRISPR technology, etc.
- Familiar with analytical technologies and detection methods for the gene & cell therapy products, including but not limited to molecular biology such as qPCR, ddPCR, bDNA, cell function determination, flow cytometry, immunogenicity detection, ELISA technology, etc., with at least 2+ years of experience in the development and verification of qPCR/ddPCR methods or large molecular bioanalysis
- Experience in verification of oligonucleotide/mRNA/AAV/CAR-T methods for quantitative analysis of qPCR/ddPCR is preferred, and experience in gene cell therapy drug declaration is preferred
- Familiarity with gene cell therapy and bioanalytical regulations, possess experience in large molecule bioanalysis
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