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.
Analytical Method Development Scientist
Critical Competencies and Qualifications:
Candidate must have a BS and at least 6 years of experience in Biology, Virology, Molecular Biology, Cell Biology, Biochemistry, or related field or M.S. and at least four years of experience in Biology, Virology, Molecular Biology, Cell Biology, Biochemistry, or related field
• Extensive knowledge in biotechnology theory and techniques. Experience in qPCR, Elisa methods development strongly preferred.
• Proven R&D skills in method development, optimization and validation.
• Proven skills in cGMP regulated analytical lab environment.
The successful Candidate must:
• Independently plan, perform and complete development activities for a compliant generation of data to support development and validation of methodologies for drug substances, intermediates and drug products
• Independently plan, perform and complete QC activities for a timely and compliant generation of data, to support QC release of drug substance and drug product
• Maintain all analytical equipment according to the schedule and Standard Operating Procedures
• Accurately upkeep documentation for a timely and compliant recording of data to support research and QC activities
• Generate, maintain and review lab data and records in accordance with company policy and according to cGxP
• Independently troubleshoot analytical instrumentation and assigned experiments; optimize existing processes and procedures
• Effectively communicate and present oral and written results to Lab Manager
• Independently and effectively plan and prioritize tasks to ensure timely and compliant completion of research and QC activities
• Independently compile and review SOPs, scientific reports and lab findings and be able to provide conclusions
• Train and mentor peers
• Introduce efficient and innovative techniques and processes with sound scientific judgement
• BS and at least 6 years of experience in Biology, Virology, Molecular Biology, Cell Biology, Biochemistry, or related field or M.S. and at least four years of experience in Biology, Virology, Molecular Biology, Cell Biology, Biochemistry, or related field
• The ideal candidate will have in depth knowledge and experience with viral cell-based assays
• Proficiency in in-vivo and cell culture, and also prefer capability in molecular biology and ELISA
• Able to work independently to develop and execute new test methods
• Able to rigorously analyze and interpret data
• Commitment to excellence and high standards
• Excellent written and oral communication skills
• Organizational, problem-solving, and analytical skills
• Ability to manage different workflows and priorities independently and efficiently
• Versatility, flexibility, and a willingness to work within changing priorities
• Demonstrated ability to evaluate results and provide conclusions
• Demonstrated ability to plan, organize and execute analytical research in accordance with company policy
• Ability to meet deadlines
• Creative, flexible, and innovative team player
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in analytical methods