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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.
We don't follow footsteps. We create the path.
Summary
The Senior Analytical 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 process characterization/validation work, collaborate with analytical science and QC teams to develop SOPs and transfer the developed assays to the corresponding teams.
Responsibilities
The major responsibilities are as follows, but not limited to:
- Independently designs and develop protein biophysical and biochemical method to characterize rAAV vector product and their associated variants and major impurities.
- Provide analytical expertise to troubleshoot and resolve technical 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.
- Write, review, edit, and approval internal technical reports, quality documents and external presentations.
Description of the essential daily job functions and % of time spent on each.
50% Working in the labs to perform experiments described above in the job primary duties
35% Design experiments, organize, discuss and record experimental data.
10% Prepare presenting materials, literature search and so on.
5% Trainings, lab meetings and administration work
Qualifications
- 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.
Key Skills, Abilities, and Competencies
Fundamental understanding of protein science, protein/peptide stability, and protein-protein interactions.
Demonstrated proficiency with biophysical and biochemical techniques (LC-MS/MS-qToF, SEC-MALS, FFF, DLS, AUC, FT-IR, RP-HPLC, IEX and HIC) for biotherapeutics characterization.
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.
Senior level role with demonstrated expert in analytical method development experience.
Develops solutions to a variety of complex analytical related challenges.
May refer to established procedures and policies.
Key Skills, Abilities, and Competencies, Cont.
Worked is performed under general direction.
Participates in determining objectives of assignment.
Plan schedules and arranges own activities in accomplishing objectives.
Work is reviewed upon completion for adequacy in meeting objectives.
Complete understanding and application of principles, concepts, practices, standards.
Full knowledge of industry practices.
Failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Represents department as a prime contact on contracts or projects related to analytical method development and qualification
Interacts well with senior internal/external personnel on significate matters often requiring coordination between organizations/departments/teams, including Regulatory, QA/QC teams, R&D, Technical Operations.
Interfaces well with senior internal/external personnel in own area of expertise on analytical method and Quality Control.