The Analytical Development Scientist is a key member of Assay/Methodology development team. The selected candidate will apply existing knowledge to develop new analytical methods and optimize existing assays to support the development of novel gene therapy programs. She/he must be able to efficiently design and execute experiments, perform data analysis to support upstream and downstream process development. Participate in process characterization/validation work, collaborate with analytical science and QC teams to develop SOPs and transfer the developed assays to internal corresponding teams and external CRO.
The major responsibilities are as follows, but not limited to:
- Develop new analytical methods to support process development and platform optimization on the efforts of removing empty capsids and DNA impurities in rAAV products.
- Serve as SME for analytical method transfer to QC and CRO.
- Design and 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.
- Understand regulatory expectation, write, review, edit, and approval internal technical reports, quality documents and external presentations.
- Provide analytical expertise to troubleshoot issues and resolve the issues timely
- Demonstrate proficiency with biological and biochemical analysis techniques (protein analysis methods and qPCR/ddPCR-based assays) for biotherapeutic characterization
- Maintain GXP compliant good documentation with high level of detail.
Education and Experience Requirements
- Working in the labs to perform experiments described above in the job primary duties
- Design experiments, organize, discuss and record experimental data.
- Prepare presenting materials, literature search and so on.
- Trainings, lab meetings and administration work
Key Skills, Abilities, and Competencies
- Ph.D in a relevant scientific discipline such as biological sciences, biochemistry, or analytical chemistry. Or BS/MS degree in a relevant scientific discipline with at least 3 years of applicable experience.
- Experience with viral vector production and characterization is preferred
Complexity and Problem Solving
- Strong analytical skills and problem-solving capabilities; Expert skills in a variety of lab techniques, including protein assay methods and qPCR/ddPCR-based assays.
- Proven ability to work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques
- Demonstrated ability to collaborate with team and to train junior staff
- Excellent organizational, record keeping, communication skills, strong technical writing skills
- Flexible and comfortable with a fast-paced and evolving business environment
- Demonstrates Spark values, especially Commit to Collaboration and Demonstrate the Respect you Seek
Internal and External Contacts
- Refers to policies and established procedures for guidance
- Strong technical expertise and capable to identify, resolve, and/or advise on technical issues related to assay development and procedures of protein analysis and qPCR/ddPCR based assays
- Develops solutions to a variety of problems of moderate scope and complexity
- Plan daily work schedule to complete tasks efficiently
- Work is generally performed independently, with moderate direction
- Work is reviewed for soundness of judgement and overall adequacy and accuracy
- Serves as SME for AD technical discussions
- Represent group/department on specific projects
- May participate/present at relevant scientific conferences and contribute to publications
- Communicates and coordinates with external vendors
- Attend scientific conferences or symposia; may present when possible
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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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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