Senior Analytical Scientist/Process and Technology Development
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 plays a key role in analytical development team.
S/he will function as an expert to design and execute experiments to develop new analytical methods.
The incumbent will provide scientific expertise on method development and assay optimization of existing assays based on in-depth knowledge and hands-on experience in bio-separations and biophysical characterization.
S/he will perform analytical experiments to support upstream and downstream process development, including process characterization, as needed.
S/he may also be involved with collaborations with Analytical Sciences and QC teams for method transfers.
The major responsibilities are as follows, but not limited to:
- Independently designs and develops biophysical and biochemical method to characterize rAAV vector product, their associated variants and impurities.
- Provide analytical expertise to troubleshoot and resolve technical issues in a timely manner.
- Conduct analytical experiments to support process and technology development
- Deliver reliable high-quality experimental data and prepare experimental reports in a timely manner.
- Write, review, and edit internal technical reports, quality documents and presentations.
Responsibilities
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, etc.
5% Trainings, lab meetings and administration work
Education and Experience Requirements
- Ph.
D in Biological sciences, 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. - Familiarity with viral vector production and experience with analytical characterization of viral vectors is preferred.
Key Skills, Abilities, and Competencies
- Demonstrated proficiency with biophysical and biochemical techniques (AUC, FT-IR, RP-HPLC, SEC-MALS, FFF, DLS, IEX and HIC) for biotherapeutics characterization.
- Expert knowledge in designing, implementing and troubleshooting of experiments
- Experience with analytical development and CMC development.
- 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.
Complexity and Problem Solving
- Senior level role with demonstrated expertise in analytical method development.
- Develops solutions to a variety of complex analytical related challenges.
- May refer to established procedures and policies.
- Worked is performed under general direction.
- Participates in determining objectives of assignment.
- Plans and arranges own activities in order to accomplish objectives.
- Work is reviewed upon completion for adequacy in meeting objectives.
- Failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Internal and External Contacts
- 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.
#LI-NBL1
.Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
