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Technical Operations Specialist

Company: Sangamo Therapeutics, Inc.
Location: Brisbane
Posted on: January 16, 2022

Job Description:

Manager:-- -Senior Manager, Manufacturing Department:-- - Technical Operations - Manufacturing 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. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today's medicines can only treat symptoms. At Sangamo, we are passionate about transforming 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. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise. -- - We are seeking top talent to join our mission. Let's build a better future together. JOB SUMMARY:-- - -- - Sangamo Therapeutics is seeking a Technical Specialist to contribute to the successful startup of Manufacturing at Sangamo Brisbane. This individual will communicate cross-functionally with multiple departments such as QA, Warehouse and Supply Chain to generate and drive the review and approval of Manufacturing and Quality documents. They will also work closely with Process Development and outside partners to support incoming and outgoing technology and process transfers. We're looking for someone who thrives in a quick paced startup environment with thoughtful and strategic decision-making skills and someone who is an effective communicator as well as an excellent technical writer. ESSENTIAL FUNCTIONS:-- - Generate/revise documents such as SOPs, raw material specifications, batch records and/or work instructions Review executed documents such as logbooks, engineering run protocols and batch records Perform deviation and OOS investigations and generate investigation summaries Initiate and drive change controls Support validation activities such as URS revision/generation, IOPQ protocol generation/review/execution/approval and qualification summary report generation/review/approval Support on-the-floor manufacturing operations in both gene therapy and cell therapy Support continuous improvements in GMP MFG EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: Minimum of Bachelor's in biology, biochemistry or other relevant life science 3+ years experience GxP in MSAT or Manufacturing groups Experience with upstream, downstream and/or cell therapy manufacturing operations is required Great technical writing skills such as SOP and batch record generation, deviation investigation and closure, CAPA implementation, etc. Working knowledge of Quality Systems used in GxP environments and Environmental, Health & Safety (EHS) standards Experience participating in risk assessments and change control Excellent communication skills such as providing cross-functional project updates, driving multi-department approvals, and informing management of blockers/delays Impeccable attention-to-detail Great time-management skills and ability to work in a fast-paced start-up environment Ability to analyze and resolve problems independently OTHER QUALIFICATIONS: Knowledge and/or experience with AAV and/or cell therapies a plus Knowledge of Phase I/II clinical manufacturing 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. -- - COVID-19 Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date.-- - This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role.-- - If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.-- - -- - Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part. -- - If you wish to be considered for the presentation of candidates, please contact us through . Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services. -- - #LI-KO1

Keywords: Sangamo Therapeutics, Inc., San Francisco , Technical Operations Specialist, IT / Software / Systems , Brisbane, California

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