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Analytical Development Scientist, Team Lead (Gene Therapy)

Company: GQR Global Markets
Location: Boston
Posted on: September 17, 2020

Job Description:

Position Summary The Scientist, Team Lead Analytical Sciences will be an integral part of our growing Process Analytics team and be responsible for executing over two dozen highly complex analytical assays supporting process development, external manufacturing and tech transfer, focused around (pre) clinical grade rAAV vectors, associated cell-based potency assays, as well as performing training of new technical staff and troubleshooting and validation of new assays for future programs. The Scientist will additionally work with various mammalian cell lines, perform analytical methods to monitor cell growth, and trend cell line quality and suitability for downstream use. Responsibilities Generate high quality, robust and reliable analytical data. Independently perform complex data analysis and keep detailed SOP driven electronic notebook records. Function as subject matter expert (SME) for technical platforms and new methodologies and support the Analytical Development team in the troubleshooting and implementation of new technology or assays. -- Implement and assist in technology transfer of methodologies to and from both internal and external groups. Train and mentor new technical staff in our assay repertoire. Oversee day to day operational management of a team of junior analysts. Manage external interactions as SME with CRO's / CMO's in matters of Tech Transfer, assay establishment, optimization, troubleshooting and qualification or validation. Write detailed SOPs and Tech reports for current and new assays to be implemented and maintain good working relationship with QA throughout the process. Requirements: A Bachelor's degree in Biotechnology, Biology or related scientific discipline with 8+ years of relevant experience, a Master's degree in related discipline with 7+ years of relevant experience, or a PhD in a related discipline with 0-2+ years relevant experience Demonstrated understanding of adeno associated viral particles, AAV serotypes and therapeutic applications is necessary. Hands-on experience preferred. Process analytics, QC or analytical development experience in an SOP driven environment is a must. Strong understanding of technical SOP / Report writing, and review procedures is a must. Experience with highly sensitive nucleotide titering assays, such as absolute qPCR and / or digital droplet PCR is a must. Hands-on experience with cell-based bioassays, such as TCID50, miRNA knockdown, viral transduction, (cell-based) potency assays is highly preferred Experience with complex chromatographic and biophysical assays, such as (U)HPLC, SEC, CE, DLS and AUC is preferred Experience with Biochemical assays, such as isopycnic gradient centrifugation, ELISA, SDS-Page / Immunoblot and denaturing DNA gels is preferred Cross-functional working knowledge of Baculovirus / SF9 platform for AAV production (upstream and downstream process) is preferred --If interested in this role, please email your resume to Jaime.Conil@gqrgm.com

Keywords: GQR Global Markets, Boston , Analytical Development Scientist, Team Lead (Gene Therapy), Healthcare , Boston, Massachusetts

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