The Analytical Development Scientist position plays a key role in Assay/Methodology development team. He/she will function as an expert to design and execute experiments to develop new analytical methods.
The incumbent will provide scientific expertise to multiple assay development projects, optimize existing assays based on in-depth knowledge of laboratory techniques. Provide scientific inputs on principle of new assay development process, technical transfer, development of SOPs and assay validation.
Perform analytical experiments to support upstream and downstream process development as needed. Participate in process characterization/validation work. Collaborate with analytical Science and QC teams to develop SOPs and transfer the developed assays to the corresponding teams.
The major responsibilities are as follows, but not limited to:
Education and Experience Requirements
- Independently designs and develop Cell-based and/or immunoassays to characterize potency of rAAV vector product and their associated variants and major impurities.
- Fundamental and proficient experience with cell-based bioassays and immunoassays
- Demonstrated proficiency with biological techniques (Viral infectivity and potency assays, ELISA, cell culture, RT-PCR, immunostaining...etc.) for biotherapeutic characterization.
- Provide analytical expertise to troubleshoot and resolve technical issues.
- Conduct analytical experiments to support process and technology development, and to deliver a reliable high-quality experimental data and prepare experimental reports in a timely manner.
- Write, review, edit, and approval internal technical reports, quality documents and external presentations.
- Demonstrated ability to support assay transfer to external vendors.
- Expert technical lab skills.
- Expert skills in synthesizing research findings and effectively communicating findings and recommendations to senior management and project teams independently.
- Acts independently to determine methods and procedures on new assignments.
- Typically, Ph.D. in Biological sciences field or BS/MS in Biological Sciences field with 5 years of related experience in biotechnology or pharmaceutical industry settings.
- Experience with viral vector production and characterization is preferred.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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