Senior QC Technician (Biochemistry, Molecular Biology Or Related)

Senior QC Technician (Biochemistry, Molecular Biology or Related)


COMPANY OVERVIEW
Shanghai JW Biotechnology Co., Ltd. (JW) is a biotechnology company dedicated to pursue innovative technology to develop cures for people with serious and life-threatening diseases.
JW has obtained exclusive licenses of multiple patents and other intellectual property owned by the Pasteur Institute and Theravectys for development, manufacture and commercialization of therapeutic products based on lentiviral vectors.
We offer lentiviral vector development, manufacturing and analytical testing for clinical and commercial supply. Our services include Process and Analytical Methods Development, Full GMP Production, with USP and DSP, Fill & Finish, Quality Control & Quality Assurance and Regulatory Support.
The GMP production facility located in Shanghai is dedicated to provide safe and reliable viral vector-based products and CMO/CDMO services, helping to translate early stage research into commercially viable therapies.
In addition, JW has established partnership with the Huashan Hospital to develop leading edge therapies for various cancers such as liver and prostate cancersas well as infectious diseases such as HBV and Tuberculosis.


Senior QC Technician is responsible for routine QC testing on raw materials, in-process and release samples.
This position will support method qualification activities including authoring protocols/reports and execution of testing and will support investigational new drug (IND) activities. We are looking for expertise in ELISA, in-vitro potency and qPCR methods.
Collaborate with cross functional teams including Manufacturing, Warehouse and Quality Assurance.

Responsibilities
• Develop, perform, troubleshoot, and optimize AAV characterization assays including but not limited to qPCR and ELISAs
• Establish and qualify assay controls, standards, and references
• Maintain cell lines used for cell-based assays.
• Maintain complete and accurate records of all work performed
• Author and/or review IQ, OQ, PQ protocols and reports as well as standard operating procedures.
• Ensure maintenance and calibration of equipment including controlled temperature environments, analytical equipment, pipettes, etc.
• Ensure laboratory supplies and required inventory are maintained
• Manage contract testing lab relationships: coordinate sample shipments, obtain results, and follow up on open action items
• Document, technically evaluate, interpret data, and trend results
• Review data for quality, consistency, and accuracy
• Write technical protocols and reports
• Perform method transfers, method qualifications etc. per approved protocol
• Conduct laboratory investigations as required
• Identify gaps, recommend process improvements, and implement changes
• Participate in continuous improvement projects and activities
• Mentor new hires
• Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
• Document writing such as: laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.


Requirements
• Bachelor’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 5 or more years of hands-on experience in QC laboratory environment OR
• Master’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 3 or more years of hands-on experience in QC laboratory environment
• Strong knowledge of QC testing principles and procedures in cell culture (aseptic technique), cell-based assays, qPCR, ELISA, DNA\RNA extraction etc.
• Experience with cGMP environments and audits
• Knowledge of equipment protocols and requirements
• Good laboratory documentation skills and protocol writing and revision experience
• Strong interpersonal and communication skills; written and oral
• Outstanding planning, organization, and multitasking skills
• Team player and meet project timelines
• Experience or knowledge of a wide range of analytical instrumentation with the ability to troubleshoot and monitor system suitability trends.
• Wiling to relocate to China


Preferred Qualifications
• Understanding of applicable regulatory requirements (21 CFR, USP, EP, ICH)

Best regards
David