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Form of workJob Description
The Scientist will support the development, validation, and transfer of chromatography and separations sciences methods in support of cell and gene therapy product development and analytical testing. The incumbent will serve as a subject matter expert in the analysis of virus products using standard and advanced chromatography techniques. This role presents a unique opportunity within the Testing and Analytical Services Department to grow diverse technical and intellectual skills in a dynamic and fast-paced environment. We are seeking an individual who is motivated by our mission, is highly organized, and a team player that is flexible to support a range of projects within a fast-growing organization. The ideal candidate will be able to function independently or in a team setting, be goal oriented, organized, highly communicative, and able to contribute to several projects.
Responsibilities- Conduct analytical method develop, optimization, qualification, and transfer of analytical methods in support of adeno-associated virus and lentivirus in-process, drug substance, and drug product characterization and product release.
- Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.
- Design, execute and interpret experiments to meet R&D objectives.
- Develop presentations and effectively communicate technical results to internal technical groups.
- Maintain an up-to-date lab notebook and relevant documentation
- Perform and coordinate analytical testing in support of process development, manufacturing, cGMP investigations, and product characterization.
- Collaborate with a diverse team to develop products for cell and gene therapy applications.
- Draft technical reports to comply with good laboratory practices.
- Generate, analyze, and record high-quality data using documentation, and database tools.
- Participate in the support of analytical activities including method qualification, data trending, troubleshooting, optimization, review and reporting.
- Review, interpret and communicates data cross-functionally within the organization.
- Attend, participate in, and present results at cross-functional team meetings.
- Author reports and source documentation to support regulatory filings.
- Bachelor’s Degree in biology, chemistry, or related discipline with >8 years of relevant industry experience, or a master’s degree with a minimum of 3 years industry experience.
- Prior experience CE-SDS, SDS-PAGE, SEC MALS, HPLC, DLS, AUC, UV spectrophotometry, and other chromatography and separations techniques is required.
- In addition, experience with ELISA techniques preferred.
- Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
- Experience developing and qualifying analytical methods for virus products required.
- Cell and gene therapy experience preferred.
- Demonstrated ability to conduct and interpret experiments to meet technical objectives
- Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively, both written and verbal.
- A proven ability to collaborate with team members to complete projects in an efficient and timely manner.
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