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.
We don't follow footsteps. We create the path.
The Senior analytical Scientist position requires a strong background and hands-on experience in developing, validating, and implementing various molecular biology and cell-based assays to support the process development of gene therapy products across all therapeutic areas. The selected candidate will apply existing knowledge to the development of new assays and methods to support process development of novel gene therapy programs.
The candidate must be able to efficiently develop and execute experiments, perform data analysis to support upstream and downstream process development. Participate process characterization/validation work, collaborate with analytical science and QC teams to develop SOPs and transfer the developed assays to the corresponding teams.
• Develop new analytical methods and optimize existing methods (DNA-based, ELISA-based and cell-based assays) based on in-depth knowledge of biological and biochemical analytical techniques to support rAAV process development and product characterization.
• Develop new analytical methods using biological, biochemical, biophysical analytical techniques as needed.
• Write, review, edit, and approval internal technical reports, quality documents and external presentations.
• Provide analytical expertise to troubleshoot issues and resolve the issues timely
• 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.
• Provide coaching and guidance to junior team members on technical issues
• Maintain GXP compliant good documentation with high level of detail.
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
• Typically Ph.D in Biological sciences, or Analytical Chemistry or Biochemistry and 3-5 years of related experience, or B.S. degree and M.S, degree in Analytical Chemistry or Biochemistry and > 3-5 years biotechnology or pharmaceutical industry experience.
• Experience with viral vector production and characterization is preferred
• Knowledge of automation strategy to support analytical testing is a plus
• Expert knowledge in designing, implementing and troubleshooting analytical method development experiments
• Expert ability to critically analyze problems, develop potential solutions and evaluate impact to business
• Ability to assume independent ownership of scientific programs, serving as an internal champion
• Demonstrated ability to independently provide effective oversight and management of external vendors
• Expert technical lab skills and skills in synthesizing research findings and effectively communicating findings and recommendations to senior management independently
• Acts independently to determine methods and procedures on new assignments.
• Provides coaching and guidance to more junior team members on technical issues
• Primary role is an individual contributor.