Job Description
Job Summary:
- Client is seeking to fill a temporary contracting role on the Process and Analytical Development team at its viral vector CDMO facility in Carlsbad, CA.
- The candidate will be responsible for the execution and development of analytical assays in support of process development activities for innovative viral vector therapeutics.
Duties and Responsibilities:
- Generate worksheets, summary reports, and method transfer documents.
- Interface effectively with both internal and external partners to communicate technical guidance and updates.
- Investigate, create, and develop new methods and technology to achieve technical objectives and advancement.
- Independently design, plan, and execute experiments.
- Independently analyze complex data and interpret results.
- Able to contribute to and execute technical transfers of analytical methods from and/or to internal and external partners.
Minimum Qualifications:
- Bachelor’s degree in chemistry, biochemistry, or related life science studies.
- 7+ years of relevant experience in biopharmaceutical industry OR
- Master’s degree in chemistry, biochemistry, or related life science studies.
- 5+ years of relevant experience in biopharmaceutical industry OR
- Ph.D. in chemistry, biochemistry, or related life science studies.
- 3+ years of relevant experience in biopharmaceutical industry.
Preferred Qualifications:
- Knowledge and technical expertise in biologics analytical techniques and method development with a focus on HPLC and CE.
- Highly experienced in using Client UHPLC system and proficient in using Client software.
- Experience in using Sciex CE system BioPhase 8800 or PA 800 Plus.
- Experience in using Wyatt SEC-MALS and FFF-MALS.
- Highly detail oriented.
- Helpful to have academic and/or industry-based background in virology.
- Critical and analytical thinking skills to effectively solve problems and improve outcomes.
- Effective communicator of scientific results.
- Knowledge of quality systems within an FDA-regulated environment.
- Knowledge of ICH quality guidelines.