Scientist, Gene Cell Therapy, Vector Method Development
Sangamo BioSciences, Inc.
Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT
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Position: Scientist, Gene & Cell Therapy, Vector Method Development Location: Brisbane, CA Job Id: R # of Openings: 1 Manager: Associate Director Department: Analytical Development (AD) Location: Brisbane, CA Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Sangamo is a company where individuals can flourish, grow and develop their expertise. We are seeking top talent to join our team. Let’s build a better future together. JOB SUMMARY: This Analytical Development (AD) Scientist will perform laboratory-based activities to design, and develop analytical methods for the characterization, release testing Company’s recombinant Adeno-associated Virus (rAAV) gene and cell therapy products. The successful candidate will be responsible for the onward gene & cell therapy vector method development, supporting in-process development as well as new method development. ESSENTIAL FUNCTIONS: – Conduct and perform analytical method development by lab work for assay development, optimization, qualification, and implementation of analytical methods for the characterization, release testing and stability testing of the Company’s gene and cell therapy drug products – Support analytical method development and characterization of AAV products by developing ddPCR, qPCR, ELISA, and other analytical assays – Develop strategies for extended analytical characterization and impurity analysis of viral vectors – Manage CDMO and CRO relationships for tech transfer and outsource testing for analytics – Independently plan and conduct laboratory experiments and provide in-depth data analysis and data interpretation – Compile / analyze data and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software – Execute experiment statistic design and data analysis; keep lab notebook and required documentation in detail, draft/write study summary and development report – Participate and represent the group in technical discussions and present findings in technical development meetings – Draft and review of SOPs, forms, test records and protocols to facilitate transfer of methods to in-house QC – GMP compliance, methods transfer and training of staff within the in-house QC department. Assist in the preparation of CMC regulatory submissions – Other activities as may be assigned EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: The ideal candidate for this position will have demonstrated in-depth experience in analytical method development, qualification, validation and be able to independently design and carry out activities supporting characterization, release testing and stability testing of AAV products. Candidate must possess: – PhD in Biological Sciences, Bioengineering or Chemistry – 2 – 5+ years of experience in the biotechnology or pharma industry with a primary focus on analytical development for AAV or other biologic products. Level will be dependent upon skills and experience – Experience of in AAV-mediated gene therapy and Cell Therapy is preferred – Can independently conduct experiment and demonstrate experience in managing according to SOP, and GMP compliance. Familiar with basic lab requirement and highly organized – Extensive hands on experience in designing and developing ddPCR, qPCR, and custom ELISA is a must. – Demonstrated experience in method development and qualification/validation is required – Detail oriented, outstanding organizational skills, excellent written and oral communication skills – Knowledge on assays methods and regulatory/pharmacopeia requirements for biologic products is a plus Sangamo is an equal opportunity employer The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time. #LI-KO1